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- 2026-05-08 21:56:56
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- Xofluza, is aiming for a rebound in sales
- by Oct 14, 2022 05:53am
- As soon as it was released, Xofluza, an unfortunate flu treatment that had little sales due to COVID-19, is seeking to rebound. As the flu pandemic warning has been issued for the first time in three years and the number of flu patients is increasing, Roche will also start selling Xofluza in earnest. ◆ New drug Xofluza for the first time in 20 years Xofluza is the next generation of flu treatment that Roche will succeed inTamiflu. Tamiflu is the only drug for new influenza and is a representative flu treatment for 20 years. Developed as a new mechanism of action in 20 years, Xofluza inhibits polymerase acid endonuclease, which is essential for cloning influenza viruses, preventing the progression from the early stages of virus replication. Xofluza dramatically reduced the number of doses. Unlike Tamiflu, which requires taking twice a day for five days, Xofluza only needs to be taken once within 48 hours of symptoms. In other words, 1 tablet of Xofluza can replace 10 tablets of Tamiflu. Xofluza, which received a lot of attention even before its approval and was approved by the Ministry of Food and Drug Safety in November 2019, had low sales due to the massive outbreak of unexpected COVID-19. As expected, sales of Xofluza had to rise from the 2020-2021 season, there were few opportunities for Xofluza to be used due to the unusually low flu epidemic for two consecutive years. This is because the entire nation is obligated to wear masks and social distancing has been strengthened. According to IQVIA, a pharmaceutical market research firm, Xofluza's quarterly sales were less than 100 million won. In the fourth quarter of 2020, which had the most sales, was only 75 million won. Despite sluggish sales, Xofluza has steadily expanded its indication. In January 2021, an indication of influenza prevention therapy was added. Xofluza can be taken as a preventive measure if in contact with an influenza-infected patient. In addition, in the United States this year, the indication has been expanded so that children aged 5 to 11 can use Xofluza. In Korea, only adolescents or adults aged 12 or older are subject to administration. Based on related research data, the age at which administration can be administered is expected to expand in Korea in the future. ◆Re-examination of Xofluza in the flu pandemic warning Xofluza, which has not been seen for two years due to COVID-19, is expecting a full-fledged increase in sales this year. This is because the flu is expected to be prevalent in the 2022-2023 season. The Korea Centers for Disease Control and Prevention issued a national flu pandemic warning for the first time since the COVID-19 pandemic. From the 4th to the 10th of last month, the proportion of influenza doctors (patients with suspicious symptoms) met the epidemic standard at 5.1 per 1,000 people and issued a pandemic warning earlier than usual. Trends in the proportion of suspected flu patients in the 2022-2023 season (Data: Korea Centers for Disease Control and Prevention) In fact, the number of patients with suspected symptoms per 1,000 outpatients is rapidly increasing. In the last week of September (September 25 to October 1), the number of patients showing suspicious symptoms per 1,000 outpatients was 7.1 per 1,000 patients, up 44.9% from the previous week. In preparation for the increase in the number of flu patients, Roche has also secured enough supplies of Xofluza. The Xofluza effect was demonstrated in phase 3 clinical trials (CAPSTONE-1, CAPSTONE-2, BLOCKSTONE). In a CAPSTONE-1 clinical trial of 1,436 patients aged 12 and over, Xofluza shortened the duration of influenza-related symptoms by more than one day compared to a placebo. It had a slight edge over Tamiflu. Xofluza significantly reduced the time to improve symptoms compared to placebo in high-risk groups aged 65 or older with a high risk of accompanying influenza complications (CAPSTONE-2). Subsequently, as a result of prophylactic administration of Xofluza to family members in contact with influenza-infected patients, the risk of developing influenza was reduced by 90% compared to the placebo (BLOCKSTONE). In order for Xofluza to be widely used like Tamiflu, it must be made. Roche attempted to register Xofluza salary in 2020 but received conditional non-payment at HIRA, the first gateway. The Pharmaceutical Evaluation Committee attached the condition that benefits are possible if the evaluation amount is less than or equal to the evaluation amount. Xofluza is still non-reimbursed as it ran parallel in the drug price negotiation process. It is not expected to be easy to apply for benefits during the 2022-2023 flu season. If Xofluza is prescribed as a non-payment, the price of the drug that the patient has to pay is known to be around 80,000 won to 90,000 won.
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- PARP anticancer drugs raise expectations of ovarian cancer
- by Oct 14, 2022 05:53am
- Lee Taek-sang, professor of obstetrics and gynecology at Boramae Hospital, Seoul Metropolitan Government As benefits are applied to the primary maintenance therapy of PARP inhibitors in ovarian cancer treatment in Korea, the treatment site is rapidly changing. Above all, a specialist evaluates that the use of PARP inhibitors for early treatment has significantly improved the patient's prognosis. However, the expansion of benefits and commercialization of HRd diagnosis in BRCA negative patients are considered tasks to be improved. ◆ Improved prognosis with recurrent ovarian cancer and PARP inhibitors Unlike other solid cancers, ovarian cancer has less remote metastasis and excellent sensitivity to anticancer drugs. Therefore, regardless of the stage of ovarian cancer, surgery and chemotherapy are considered the first-line treatment. However, the initial symptoms were insignificant, so cancer was often diagnosed after progression, and eight out of 10 patients suffered recurrence after the first treatment, making treatment difficult. PARP inhibitors have made new changes in the treatment of ovarian cancer. In the past, in addition to cytotoxic anticancer drugs, vascular endothelial growth factor (VEGF) inhibitors have appeared, but they were far from customized treatments due to specific biomarkers. PARP inhibitors were able to perform customized treatment according to biomarkers such as BRCA and homologous recombination deficiency (HRd). In an interview with Dailypharm, Lee Taek-sang, a professor of obstetrics and gynecology at Boramae Hospital, said, "PARP inhibitors have improved ovarian cancer prognosis and changed the treatment paradigm with survival rate. The PARP inhibitors used in Korea are Takeda's Zejula and AstraZeneca's Lynparza. Recently, PARP inhibitors in the U.S. have withdrawn their indications for the fourth or higher treatment of ovarian cancer, but the impact is expected to be minimal as both drugs are used in early treatment such as primary maintenance therapy. ◆ Same but different Zejula Lynparza Zejula and Lynparza show some differences in primary maintenance therapy. Basically, both drugs are used as maintenance therapy in platinum-sensitive patients, while Zejula can be used regardless of BRCA or HRd, while Lynparza can be used alone in BRCA-positive and in combination with Avastin in HRd-positive patients. Professor Lee said, "Lynparza is also likely to be effective in patients without BRCA or HRd mutations, but there is no indication because it was only for patients with BRCA mutations in the clinical trial on the basis of permission." Zejula added that through large-scale phase 3 clinical trials, consistent data are also available in BRCA-negative and HRp (homologous recombinant negative) patients. Health insurance benefits apply only to BRCA-positive patients on both drugs. In addition, when Lynparza is used as primary maintenance therapy, the benefit is applied only up to two years after initial administration, while Zejula can be used continuously until recurrence. This is because the follow-up period was only up to two years in clinical trials on which Lynparza permits were based. In addition, the two drugs also show differences in the number, dose, and safety profile of the drug. This difference is the standard for selecting drugs in the clinical field. Professor Lee said, "Lynparza is taken twice a day, but Zejula is taken only once a day. In addition, Zejula has data that shows consistent treatment effects even with adaptive doses, he said. "The more worrisome part is the benefit recognition period, and patients taking Lynparza are converted to non-reimursement two years after the benefit is applied," he said. ◆What is the direction of ovarian cancer treatment? The disappointing part of the benefit standard is the BRCA-negative patient. Zejula also demonstrated consistent benefits in BRCA-negative patients but was not recognized for benefit adequacy in the group. Professor Lee said, "It is certain that Zejula is helpful in this patient group, but the patient has to make a difficult decision because the drug has to be used as a non-payment." For HRd biomarkers, improving the diagnostic environment is a priority. Unlike the BRCA test, the HRd test method has not yet been commercialized, so it is limited to some institutions on a trial basis. The cost of the test also amounts to 5 million won. It is judged that more patients will be able to benefit from PARP inhibitors only when an environment where HRd tests can be freely used at the medical site is created. Professor Lee said, "If the results show that PARP inhibitor + Avastin combination therapy is more meaningful, the treatment pattern and paradigm can be changed again. In this case, the drug will be selected in consideration of the side effects and cost problems caused by Avastin, he said. "If the non-inferiority results show that there is no significant difference between the two treatments, it is expected to be a landslide victory for PARP inhibitor alone."
- Company
- The release of a flu vaccine exclusively for the elderly
- by Oct 13, 2022 06:09am
- The development of domestic companies is still far away. In order to prevent influenza (flu) infection in the elderly, a high-performance vaccine with improved preventive effects will appear in Korea. One of the two representative products has been approved in Korea, and the other is likely to be introduced. According to the pharmaceutical industry on the 13th, CSL Seqirus's tetravalent flu vaccine Fluad, which contains immunostimulants for the elderly aged 65 or older, has completed domestic approval and is preparing for its introduction. Due to the schedule, it is difficult to sell in the 2022-2023 season, but it is expected to be released next year during the flu season. Sanofi is also considering introducing a high-dose flu vaccine in Korea for those aged 65 or older. In the United States, it has been sold under the name Fluzone since it was approved in 2019. ◆ Influenza vaccines that have increased effectiveness for the elderly with reduced immunity appear Older people aged 65 or older are considered high-risk groups for flu, so active prevention is recommended with vaccination. Korea provides free flu vaccinations to senior citizens aged 65 or older through NIP. However, with conventional vaccines, the preventive effect tends to be somewhat reduced in the elderly with a reduced immune system. Accordingly, flu vaccine developers have started to develop new vaccines to increase preventive effects. Fluad, developed by CSL Seqirus, can improve the immune response by adding an immune enhancer called MF59. MF59 is an immune enhancer made using squalene ingredients produced in the liver. MF59 induces a cellular immune response to promote antigen absorption by antigen-presenting cells, thereby increasing the immune response through the activation of T cells and B cells. Even with a small amount, it can exert a strong antibody effect. MF59 was also used during the swine flu epidemic in 2009. According to a study by CSL Seqirus comparing the difference in disease burden according to the type of vaccine for senior citizens aged 65 or older in Korea, it is predicted that the burden of flu-related diseases will be significantly reduced when switching from the existing flu vaccine to a vaccine containing immune enhancers. Vaccines containing immunostimulants are expected to prevent 35,390 cases of flu, 1,602 cases of flu-related complications, 709 cases of hospitalization, and 145 cases of deaths per year compared to existing vaccines. Fluzone, developed by Sanofi, is a product that increases the number of antigens, unlike Fluad, which has added immune enhancers. It is known to have four times more antigens than existing doses. It was first approved in the U.S. in 2019 and is considering introducing in Korea. It is predicted that vaccinations with high doses will reduce the burden of diseases similar to vaccines containing immunostimulants. ◆ Vaccination for the elderly being reorganized with high-performance In the United States, flu vaccines for the elderly are changing mainly to high-performance products. This is because the analysis of studies in recent years has proved that high-performance vaccines are more advantageous in reducing the risk of hospitalization and death in the elderly over 65. In terms of safety, side effects such as pain at the injection site were reported more frequently after high-performance vaccination, but they were resolved naturally over time. Based on this, the U.S. ACIP revised its flu vaccination guidelines and recommended that senior citizens aged 65 or older receive a high-dose flu vaccine (Fluzone) or a flu vaccine containing immunostimulants. On top of that, only recombinant vaccines containing three times more antigens than existing vaccines were additionally included in the recommendation list for vaccination for the elderly. When the domestic high-performance flu vaccine market opens, multinational pharmaceutical companies are expected to dominate the market for a while. This is because only one domestic company is developing a high-performance flu vaccine, and even this has been slow to develop. GC Pharma has started developing GC3114, the first high-capacity flu vaccine in Korea. In 2018, the phase 2 clinical trial plan of GC3114 was approved and the clinical trial was completed the following year, but it was found to be in a holding state for three years. It is estimated that it will take more than five years to commercialize it as it has not yet entered phase III and has not set a specific schedule.
- Company
- How about collaboration?
- by Kim, Jin-Gu Oct 13, 2022 06:09am
- 4th largest population in the world, the advantage of clinical performance. Indonesia is emerging as a new market for the Korean pharmaceutical bio industry. In addition to the potential of being the world's fourth-largest population, the pharmaceutical market seems to be expanding rapidly as national income has recently increased overall. In line with this trend, the Indonesian government is strengthening benefits for locally produced drugs. Analysts say that for Korean pharmaceutical bio companies seeking to enter Indonesia, establishing local subsidiaries or collaborating with Indonesian companies will be an effective strategy rather than directly exporting. ◆ Indonesian government emphasizes local production On the 12th, "Global Bio & Pharma Plaza 2022" was held at Lotte Hotel World in Songpa-gu, Seoul, hosted by the Ministry of Trade, Industry and Energy. Dr. Banun attended the "Pharmaceutical Overseas Advancement Strategy Briefing" held together on the same day at the Indonesian Ministry of Health to explain the recent changes in Indonesia's policy to foster the pharmaceutical industry. According to him, the Indonesian Ministry of Health has been planning to foster the pharmaceutical and medical device industries with a 10-year long-term plan since 2016. The key is to encourage the production of medicines, raw materials for medicines, and medical devices in Indonesia. Tinkat Komponen Dalam Negeri (TKDN) was specified, and for raw material drugs, the proportion of domestic production was increased to 65%. Through this, the Indonesian government's goal is to reduce the high dependence on imports of raw materials and drugs. Dr. Banun said, "By 2024, we will make efforts to develop the pharmaceutical industry at the national level." He said, "In particular, we are focusing on the domestic manufacturing and production of medicines. "We will spare no financial support for the domestic production of major drugs," he explained. "Whether it's raw material or finished product, it's giving a lot of benefits to companies that produce medicines in Indonesia," he said. He said, "We are attracting overseas pharmaceutical companies by establishing free economic zones along with special tax cuts. "If Korean pharmaceutical companies collaborate with Indonesia, we expect good results," he stressed. ◆"Daewoong and Chong Kun Dang's cooperation with local companies, best practices for entering Indonesia" Dr. Banun cited Daewoong Pharmaceutical and Chong Kun Dang's entry into Indonesia as an exemplary example. Among Korean pharmaceutical companies, Daewoong Pharmaceutical entered Indonesia in 2012 and Chong Kun Dang in 2015 through joint ventures with local companies. Daewoong Pharmaceutical completed the construction of a pharmaceutical plant in Surabaya in cooperation with local pharmaceutical company Infion. This factory is certified halal for medicine. Currently, it ranks first in the anemia treatment (EPO) market in Indonesia. Chong Kun Dang entered the local market through a joint venture with another local pharmaceutical company, OTTO. In 2018, it completed the first halal-certified anticancer drug plant in Indonesia. Dr. Banun emphasized the "halal certification" received by the two pharmaceutical companies. Halal certification is essential in addition to its own GMP certification to enter Indonesia, he explained. "Daewoong Pharmaceutical and Chong Kun Dang have successfully established themselves as halal-certified pharmaceutical companies," Dr. Banun said. "It is a successful case of cooperation between Korean and Indonesian companies." Dr. Banun said, "In Indonesia, Halal certification is required. If there is a Korean company entering Indonesia, (the Ministry of Health of Indonesia) will help with quick certification, he said. "If we get halal certification here, it will be easy to enter the Middle East or other Southeast Asian countries that need the same certification." ◆ Interested in cooperation with Korean pharmaceutical companies in drug and health product development" In the case of Genexine, a joint venture named Kalbe and KGBIO is being established and developing immuno-cancer drugs GX-17 and new anemia drug GX-E4. "In the case of Indonesia, it has the advantage of conducting clinical trials as the world's fourth-largest population," said the CEO. "In recent years, interest in health products has also been heating up." "We are interested in developing cooperative relationships with Korean pharmaceutical companies that have excellent health products," he said.
- Company
- Dupixent's child benefit expands after over 1 1/2 yrs
- by Eo, Yun-Ho Oct 13, 2022 06:08am
- Discussions on expanding insurance benefits for children and adolescents of Dupixent, a treatment for atopic dermatitis, have been slow. According to related industries, Sanofi-Aventis Korea's Dupixent 200mg passed the Drug Benefit Standards Subcommittee in May, but has yet to be submitted to the Drug Benefit Evaluation Committee. The drug was applied for benefit expansion in March last year, but it is still in the early stages of the registration process. Earlier, Dupixent spent seven months until the expert opinion inquiry began last year. As it is an expensive new drug and it was not easy to register for the first time, it is believed that difficulties are also being followed in the discussion of expansion. Although detailed indications are different, there is a clear difference in speed compared to JAK inhibitors such as Lilly Oluminant and Abbvie Rinvoq, which belatedly submitted applications for expansion of atopic benefits. JAK inhibitors are also relatively inexpensive. Both drugs have been reimbursed since May. Since it is a risk-sharing agreement drug and a separate dose of 200mg has been added, it has to go through negotiations with the NHIS as well as HIRA's cost-effectiveness review process in the future. It remains to be seen whether Dupixent will be able to reach an agreement with the government and expand child benefits. Dupixent's health insurance coverage criteria are both 23 or higher EASI (Extremely severe eczema) even if symptoms are not controlled and systemic immunosuppressants are administered for more than 3 months, or if Dupixent is not available due to side effects. This corresponds to 300 mg.
- Company
- Status of antidiabetic SGLT-2 inhibitors rise with use in HF
- by Oct 13, 2022 06:08am
- SGLT-2 inhibitors that were initially released as a diabetes treatment have expanded their scope and risen as a representative heart drug. In addition to Heart Failure with reduced EF (HFrEF) and Heart Failure with mildly reduced EF (HFmrEF), SGLT-2 inhibitors have also demonstrated an effect in Heart Failure with Preserved Ejection Fraction (HFpEF), transforming heart failure guidelines in Korea and abroad. The heart failure treatment effect of SGLT-2 inhibitors, which was first demonstrated with Jardiance (empagliflozin), was confirmed with Forxiga (dapagliflozin). In the EMPEROR-Preserved clinical trial on HFpEF patients, Jardiance succeeded in reaching the primary efficacy endpoint. Then, Forxiga demonstrated its effect in HFrEF and HFpEF patients in the DELIVER trial. Based on such grounds, the Korean Society of Heart Failure (KSHF) published a newly revised Heart Failure Clinical Practice Guidelines and recommended SGLT-2 inhibitors as a main treatment regardless of the patient’s diabetic status in all areas of heart failure including HFrEF, HFmrEF, and HFpEF. The US has also recommended SGLT-2 inhibitors as the main drug in the guidelines for the treatment of heart failure. Some have compared the SGLT-2 inhibitor to a '21st-century statin' and predicted that it will become a standard of care in heart failure. Dailypharm met with professor Javed Butler from the University of Mississippi Medical Center in Jackson and Professor Seok-Min Kang from the Yonsei University College of Medicine (Chair of KSHF) to highlight the changes SGLT-2 inhibitors brought to the heart failure treatment paradigm. -Among SGLT-2 inhibitors, Jardiance was the first to present data demonstrating an effect on all heart failures including HFpEF. What significance does this hold and how was Jardiance able to become the first SGLT-2 inhibitor to demonstrate such data? ? Prof. Butler: Jardiance marked two milestones in the history of heart failure treatments. First, the drug was the first to demonstrate a reduction in cardiovascular deaths in diabetes patients in 2015 through the EMPA-REG OUTCOME trial. Also, the drug holds significance for being the first to demonstrate clinical efficacy in HFpEF, an area where no treatment option exists, through the EMPEROR-Preserved trial. In patients with HFpEF, Jardiance reduced the relative risk of hospitalization from HF or cardiovascular deaths by 21% and reduced the relative risk of all hospitalization from HF by 27%. This is significant because it can be felt in the field while treating patients, beyond being simply statistical figures. Although the cardiac ejection fraction rate will continue to serve as a key indicator in determining the type of heart failure and the according treatment method, it will not hold much meaning in determining the use of SGLT-2 inhibitors. Furthermore, when discussing treating heart failures, we usually discuss treatment in the spectrum of HFrEF to HFpEF. However, as SGLT-2 inhibitors have also demonstrated a relative risk reduction in the development of new heart failure events in patients with Type 2 diabetes, I would like to expand the spectrum and discuss extending its use to prevention as well. For patients with diabetes or chronic kidney disease (CKD), the best time for them to start treatment with SGLT-2 inhibitors is at the ‘pre-heart failure’ stage. -When comparing the two representative SGLT-2 inhibitors Jardiance and Forxiga, Jardiance showed a slight reduction in effect in the patient group with an ejection fraction rate of 65% or higher, but recent data on Forxiga showed that its effect remained constant in these patients. How should we interpret this difference? Professor Javed Butler Prof. Butler: It would be difficult to say that the results signify any difference between the two drugs. Based on the primary efficacy endpoint, it is difficult to say that the drugs show different efficacy in different ranges of ejection fraction rate. Only in the secondary efficacy endpoint does Jardiance show a slight reduction in effect in the group with an ejection fraction between 65-70%. However, as the drug’s efficacy rises again in the group with an ejection fraction rate of 70% or higher, the measure in the EF of 65-70% group has to be considered a noise that arose in the process of conducting the subgroup analysis. Even when taking into account the biological mechanism and principle of action of SGLT-2 inhibitors, it is difficult to provide a reasonable explanation on why its effect decreases in the EF of 65-70% group and rises again in the EF of 70% or higher group. When looking at the trend lines of clinical trials conducted on Forxiga and Jardiance, although the two may seem contrasting, it is difficult to see the difference as a clear signal indicating a significant difference when comprehensively analyzing the overall data. Also, a comprehensive meta-analysis of these data shows a fairly consistent effect across the entire cardiac ejection fraction rate spectrum. -Then, rather than discuss which drug is better, should we understand that SLGT-2 inhibitors have a class effect? Prof. Butler: It is too soon to consider it a class effect. Of course, the clinical trials of the two drugs that were conducted on patients with HFrEF and HFpEF showed consistent results. However, as we saw in various cases where the results were different after expecting such a class effect in the past, it is hard to prescribe SGLT-2 inhibitors while expecting a class effect. In other words, it would be difficult to put other SGLT-2 inhibitors on the same line other than the two drugs that have proven their treatment effect in heart failure. -The 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure gave a Class 2A recommendation for SGLT-2 inhibitors to treat HFpeF. How was the recommendation for the guideline determined at that level? Prof. Butler: There had been no other treatment option recommended in HFpEF before then. We used diuretics to treat congestion or were at the level of dealing with comorbidities. The US was the first to revise the major practice guidelines for heart failure in HFpEF after the Jardiance trial results were presented. The recommendations were changed based on the convincing trial results. However, the US guidelines require at least 2 related studies to recommend a treatment as Class 1 when revising guidelines. At the time of the revision, only one study - EMPEROR-Preserved – existed for SGLT-2 inhibitors, which was why it was not given a Class 1 recommendation. In Korea, SGLT-2 inhibitors have a Class 1 recommendation in HFpEF. I believe this is a more reasonable and advanced decision than the one made in the Us guidelines. With more relevant data being presented, I believe the US and European guidelines will also be revised to follow Korea’s guidelines. -Until now, the Korean practice guidelines mostly followed those in Europe and the US. What enabled your society to make such a bold decision this time? Prof. Kang: Korea lacks the conditions to conduct large-scale randomized clinical studies like Europe or the United States. This is why Korea commonly sets guidelines by adopting or accepting results from foreign clinical studies. We underwent various voting and debates to determine the level of evidence for several drugs before releasing our heart failure guidelines on July 22nd. Also, the DELIVER trial on Forxiga was scheduled to be presented at the European Society of Cardiology (ESC) Congress 2022 in August. We already knew the top-line results and were able to analyze the results to some extent. Considering how the prevalence of heart failure in Korea will continue to increase rapidly, the prevailing opinion was that it is reasonable to defiantly recommend a good treatment option as soon as possible. -You also mentioned SGLT-2 inhibitors should be used for prevention as well. At what scope are SGLT-2 inhibitors being prescribed in the US? Prof. Butler: As SGLT-2 inhibitors were first introduced to treat diabetes, it was mainly used by primary care doctors or endocrinologists that commonly treat diabetes. In cardiology, there is still a perception that SGLT-2 inhibitors are used to treat diabetes. Therefore, several heart failure-related societies are making efforts to raise awareness of SGLT-2 inhibitors as a treatment that can reduce cardiovascular risk, regardless of the patient’s diabetic status SGLT-2 inhibitors are being moderately used as a treatment for heart failure. However, compared to ARNis, its usage is increasing relatively quickly. -In Korea, the drugs would need to also receive reimbursement in the indication, but setting the reimbursement standards for SGLT-2 inhibitors may also be a difficult task. Even when basing the standards on the cardiac ejection fraction rate, it would be difficult to apply for reimbursement benefits according to the specific ejection rate. Prof. Kang: I cannot say what would be the clear standard for reimbursement, and this area would need to be considered further. When using the level of ejection fraction as a standard, we could set an arbitrary level and reimburse all substandard drugs for other class drugs, but for SGLT-2 inhibitors, we would need to contemplate what should be considered a normal ejection fraction rate. - So SGLT-2 inhibitors are now set in the forefront of heart failure treatment. Are there any tasks we need to solve to select patients that will benefit more from the use of SGLT-2 inhibitors or any precautions that need to be taken? Prof. Butler: SGLT-2 inhibitors are more of a supplement than a replacement of existing drugs. We need to first focus on starting drug treatment as soon as possible, and take into consideration the patient's condition, including blood pressure, cardiac and kidney condition, to start administration of drugs in the appropriate order so that patients can receive all 4 drugs within 3-4 weeks of initial administration. In most cases, we can add SGLT-2 inhibitors without regulating the use of the existing drugs, however, patients who are old, have hypotension, or dehydration may need to reduce their diuretic dose, etc. Prof. Kang: As there are many phenotypes of HFpEF, more follow-up studies on the use of SGLT-2 inhibitors in these various patients would be needed. Some may oppose the prospect that SGLT-2 inhibitors may be beneficial across the entire cardiac ejection fraction rate spectrum. Therefore, data supporting how effective SGLT-2 inhibitors are for the various characteristics of heart failure is needed.
- Company
- The third PD-1 immuno-cancer drug is about to enter Korea
- by Eo, Yun-Ho Oct 12, 2022 05:50am
- It is predicted that additional immuno-cancer drugs with PD-1 inhibitory mechanisms will enter the domestic market. According to related industries, the Ministry of Food and Drug Safety is reviewing the final approval of PD-1 inhibitor Jemperli, which GSK Korea submitted an application for permission in March. Approval is possible as early as this year. If Jemperli is approved, it will be the third PD-1 inhibitor after Opdivo and Keytruda. Unlike the two drugs that took the first indication as a treatment for melanoma, this drug was first approved in the United States in April last year as a treatment for "reoccurring or progressive endometrial cancer" indicating a defect in platinum-based therapy or subsequent inconsistency recovery. Jemperli demonstrated its validity through a multi-cohort clinical trial GARNET study involving patients with recurrent or progressive dMMR/MSI-H endometrial cancer that progressed during or after platinum-based chemotherapy. As a result, RR was 43.5% and DCR was 55.6% after Jemperli treatment. The duration of the reaction has not yet reached the median value, and the rates at which the reaction lasted for 6 months and 12 months were 97.9% and 90.9%, respectively. In addition, in August of the same year, Jemperli obtained additional approval for recurrent or progressive solid cancers of adult replication error recovery defects (dMMRs) that did not reach satisfactory results with existing treatment. Jemperli recently confirmed its efficacy in non-small cell lung cancer. GSK announced positive headline results on the 5th that it met the primary evaluation variables RECIST and ORR goals in a phase 2 PERLA clinical study. The study compared Jemperli and chemotherapy combinations and Keytruda and chemotherapy combinations in primary care patients with NSCLC.
- Company
- Reimb for Ilaris unclear... benefits 13 patients in Korea
- by Eo, Yun-Ho Oct 11, 2022 05:51am
- As well expected, no progress has been made in reimbursing ‘Ilaris,’ an orphan drug that affects 13 patients in Korea. According to industry sources, reimbursement discussions for Ilaris (canakinumab), Novartis Korea’s Hereditary recurrent fever syndrome treatment that the company applied for in the first half of the year is making slow progress. The company had reapplied after receiving a non-reimbursement decision from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in 2017, but the government nor the company seems to be finding a way. Among the various specific syndromes that accompany a hereditary recurrent fever, Ilaris is approved in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF) due to contraindication, intolerance or lack of efficacy. Although the drug had demonstrated an improvement in quality of life and convenience in administration with its 6-times-a-year administration in CAPS patients, the drug had difficulty proving its cost-effectiveness, being a treatment for an ultra-rare condition and because a relatively cheaper option ‘Kineret (anakinra)’ is being supplied through the Korea Orphan & Essential Drug Center. In fact, Novartis first applied for reimbursement in 2017 after it was initially approved in 2015. However, the company did not proceed with the reimbursement process again until recently after the setback in 2017. Anticipation had risen for its reimbursement with the reapplication filed this time but to no avail. Unlike Kineret which is administered every day, Ilaris offers a more convenient option to patients and carers alike, as it is administered every 8 weeks. Dae-Chul Jeong, Professor of Pediatrics at Seoul St.Mary’s Hospital, said, “Access to such treatments needs to be improved so that patients with hereditary recurrent fever in Korea are guaranteed the same right to receive treatment as other patients with rare diseases. In addition, “Patients with hereditary recurrent fever are diagnosed after a difficult journey. We need to provide social attention and support so that patients can maintain the quality of life with their families without being discouraged at the threshold of treatment." Meanwhile, in a clinical study, 97% of the patients that were administered Ilaris 150mg achieved a complete clinical response by Week 8 through a single administration during the open-label study period. In the double-blind, placebo-controlled study period, all patients who were administered Ilaris 150mg every 8 weeks maintained their complete response without relapse for over 6 months. Also, in a real-world study that was conducted in France that compared 68 adult and pediatric patients that received at least one dose of Ilaris at baseline, at 6 months and 12 months, over 40% of patients with CAPS who were treated with Ilaris showed an improvement in vitality such as social function, human relationship, and sexual activity, and the patient care period of carers reduced significantly.
- Company
- Hemlibra, emerged as an issue of the National Audit Office
- by Nho, Byung Chul Oct 11, 2022 05:50am
- As the administration of non-antibody patients has been delayed for more than three years since Hemlibra, an innovative new drug for hemophilia A, is expected to emerge as a topic of the parliamentary audit. Representative Kang Sun-woo (Democratic Party of Korea), a member of the Health and Welfare Committee, will question the issue of the benefit of hemophilia new drug Hemlibra at a parliamentary audit of HIRA held on the 13th of this month. Kim Kyung-Hwa, a mother of a hemophilia patient with type A as a representative of the Korean Hemophilia Association, will attend as a reference. She is expected to urge health authorities to apply for Hemlibra's delayed health insurance benefits, explaining the problems of existing treatments that should be used to prevent bleeding and why subcutaneous injections are needed at the National Audit Office. Hemlibra is used as a new innovative treatment for many hemophiliac patients, achieving the No. 1 global market share, but the application of benefits is being delayed in Korea. Hemlibra, a type A hemophilia treatment imported by JW Pharm in charge of domestic permission and sales, was first approved for sale as a treatment for antibody patients in January 2019 and was first listed in May 2020, and limited standards have been resolved several times since then. In September last year, the Anti-Corruption and Civil Rights Commission recommended a review of the standards, allowing young children to be prescribed Hemlibra without undergoing two to three years of intravenous treatment. The problem is that 90% of about 1,800 hemophilia A patients are non-antibody patients. Hemlibra added an indication for non-antibody patients in March 2020 and applied for benefits in July of that year, but health insurance benefits have not been used even after two years. According to the academic society and replotting organizations, the expansion of Hemlibra's standards was confirmed at the third subcommittee held at the Review Board in July. Looking at the clinical usefulness, Hemlibra judged that it was also worth paying for non-antibody patients. However, the future is a problem. Even if it has passed the subcommittee, it must go through the HIRA Drug Benefit Evaluation Committee and negotiate drug prices and usage with NHIS. Currently, the Drug Benefit Evaluation Committee does not know when it will be held. Hemlibra is the only existing hemophilia A treatment that has been approved for use as a preventive therapy for both antibody and non-antibody patients. It imitates the mechanism of action of the coagulation factor VIII with the first-in-class applied with the technique of simultaneously binding to the coagulation factors VIIII and X, Unlike conventional treatments that supplement the 8th coagulation factor with such a mechanism, antibody production is not risky. The patient's pain was dramatically improved when taking existing drugs with subcutaneous injections up to once every four weeks. In the case of conventional hemophilia treatments, intravenous injections should be performed at least twice a week. In August, the results of phase 3 clinical trials were published in Blood advises that hemophilia A patients with hemophilia administered with Hemlibra had fewer side effects of bleeding during surgery. The result is that the risk of bleeding during surgery is low in a situation where efficacy and safety have been proven as a law.
- Company
- Will the premium vaccine market rebound?
- by Kim, Jin-Gu Oct 11, 2022 05:50am
- Whether the premium vaccine market, which consists of vaccines used to prevent diseases like shingles, pneumococcal vaccines, etc., will be able to overcome the COVID-19 crisis and make a rebound is gaining attention. Expectations of market recovery are rising in the pharma and bio-industry with the eased resurgence of COVID-19, cautious expectations on the nearing end of the COVID-19 pandemic, and potential new product releases being in the two vaccine areas. ◆Shingrix expected to be released at the end of the year...Will the contracted market rebound after COVID-19 According to industry sources on the 8th, GSK and GC Pharma plan to jointly promote the sales of the new shingles vaccine, Shingrix. Shingrix is a vaccine that prevents shingles in immunocompetent adults 50 years and older, and adults 18 years and older who are or will be immunocompromised. GSK received approval for the drug from the Ministry of Food and Drug Safety in September last year. Although the company had originally planned to release the drug in February this year, the schedule was delayed. Currently, two products - MSD's ‘Zostavax’ and SK Bioscience's ‘SKYZoster’ – are competing in the domestic shingles vaccine market. MSD The market had greatly contracted with the prolonged COVID-19 crisis. The continued prioritization of COVID-19 vaccines resulted in a relative neglect of other vaccine products. According to the medical research institution IQVIA, the domestic shingles vaccine market, was KRW 89.9 billion in 2019, a 3% increase from that in 2018. However, since the outbreak of the COVID-19 crisis, the market size shrunk for two consecutive years to KRW 72.3 billion in 2020 and KRW 45.1 billion in 2021. Compared to 2019, right before the COVID-19 crisis, the market shrunk to nearly half in two years. ◆Applying NIP to shingles vaccine under review... expectations rise for market expansion The pharmaceutical industry predicts that the market will normalize after next year after the COVID-19 crisis starts settling down. In particular, as the Suk-Yeol Yoon administration is reviewing including the shingles vaccine in the National Immunization Program (NIP), some are projecting that the market will further expand, even to a greater extent than before the COVID-19 crisis. During the elections, President Suk-Yeol Yoon who had been a candidate then had pledged to apply NIP to shingles vaccines. Quarterly sales of shingles vaccines in Korea(Unit: KRW 0.1 billion, IQVIA) The key point of the issue is how much influence the third shingles vaccine will exert in the market. By vaccine effect, Shingrix has a higher prevention rate than the existing two products. The prevention effect of Shingrix, which is indicated for adults aged 50 years and older were found to be 97% at 3.2 years after vaccination in the ZOE-50 clinical trial. Its competitor, Zostavax has shown a 51% preventive effect in adults aged 50 years or older and a 41% effect in adults aged 70 years or older. SKYZoster has demonstrated non-inferiority to Zostavax in a clinical trial. By prevention rate, the vaccine has no significant difference from Zostavax. However, its price is expected to be higher than that of existing vaccines due to its excellent preventive effect. Currently, the price of Zostavax is in the middle KRW 100,000 range, and SKYZoster is in the lower KRW 100,000 range. If the price tag of Shingrix is set too high, it may not enjoy a performance up to expectations in the market. At the same time, this will also act as a barrier to its entry into NIP. How well the two existing products will maintain their share of the market also remains to be seen. Currently, SKYZoster had been chasing Zostavax’s sales. SKYZoster’s shares in the market had been rising since it was released in Q4 2017. Shares of SKYZoster, which had been 35% in Q1 2018, rose 8%p and 43% in 4 years since Q1 this year. ◆MSD·Pfizer to introduce next-generation pneumococcal vaccines in Korea in full-scale New products are also soon to enter the pneumococcal vaccine market as well. Pfizer received marketing authorization for ‘Prevenar 20’ in the US in June last year. Prevenar 20 is an upgraded version of its existing product, ‘Prevenar 13.’ Prevenar 13 prevents 13 serotypes, and Prevenar 20 prevents 20 serotypes. MSD has also developed a next-generation pneumococcal vaccine. MSD received approval for its ‘Vaxneuvance’ from the US FDA in July last year. Vaxneuvance prevents 15 serotypes of Streptococcus pneumoniae. Although its scope of prevention is narrower than that of the existing vaccine 'Prodiax23', it has excellent preventive effects in that it is a conjugate vaccine, not a polysaccharide-based vaccine. The industry expects the two vaccines to be introduced to Korea after next year. MSD Korea submitted a market authorization application for Vaxneuvance in March of this year. Pfizer Korea is expected to apply for market authorization for Prevenar 20. An East Asian clinical trial with a total of 1,400 patients including 500 Korean patients are currently underway for Prevenar 20.
