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- 2026-04-15 11:06:03
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- Korean-made new drug Rolontis readies for FN drug market
- by Moon, sung-ho Mar 24, 2021 05:45am
- Hanmi Pharmaceutical is readying for the febrile neutropenia (FN) treatment market for its first bio new drug Rolontis (eflapegrastim), as it finally received the South Korean health authority’s market authorization. This could be an opportunity for the South Korean company to take over the domestic drug market, currently led by global pharmaceutical companies. # On Mar. 18, South Korea’s Ministry of Food and Drug Safety (MFDS) approved the marketing of Hanmi Pharmaceutical's 'Rolontis' as the 33rd new drug developed in the country. At the same time, Hanmi Pharm entered the countdown of Rolontis' entry into the U.S. market. The U.S. Food and Drug Administration’s (FDA) `pre-approval inspection (PAI),’ previously delayed due to COVID-19 pandemic, has been scheduled in May. A ‘long-term use' new drug, is it a blockbuster drug material? FN refers to an abnormal decrease in neutrophils, which must occupy 50 percent to 70 percent of white blood cells. There are many factors that cause FN, but it is typical that most cancer patients develop FN due to several anticancer treatments. For this reason, treatments are mostly prescribed for the prevention or treatment of FN caused by anticancer treatment. It has been prescribed for all carcinomas in recent years, including leukemia and breast cancer. Professor Park Inkeun of Oncology Department at Gachon University explained, “Neutrophils are a type of white blood cell and, in simple terms, are responsible for defending against bacterial infection. When chemotherapy is performed, the number of neutrophils decreases, but it recovers over time. However, a treatment is prescribed because there is a risk of infection occurring at the stage of decreasing neutrophils.” The professor added, “Just as people drink differently, the amount of neutrophil reduction is different for each patient. In particular, it could be fatal for elderly patients. For this reason, FN treatments are also administered for prevention purposes every chemotherapy cycle. It's not a one-off shot.” Then, how about the competitiveness of Rolontis in the market? #The FN treatment market in the past used to be dominated by granulocyte colony-stimulating factor (G-CSF) drugs, but recently next generation G-CSF drugs for preventive purpose are expanding in the market. At the moment, the market is dominated by Amgen’s Neulasta (pegfilgrastim), which Kyowa Kirin Korea is supplying to the South Korean market. Meanwhile, Hanmi Pharmaceutical disclosed the data collected from two global Phase II trials (ADVANCE and RECOVER) facilitated by the company’s partner Spectrum Pharmaceuticals. The two trials conducted on 643 early-stage breast cancer patients with FN caused by anticancer treatment confirmed the safety and efficacy of Rolontis. Within total four treatment cycles, Rolontis, compared against its competitor Neulasta, demonstrated non-inferior duration of severe neutropenia (DSN) and superior reduction of risk. Healthcare providers reserve opinion on Rolontis dominating the market Hanmi Pharmaceutical is planning to go through an official domestic market release process as it obtains the world's first approval for Rolontis in South Korea, regardless of the approval by the U.S. FDA. The size of the domestic market for FN drug is estimated at 80 billion won. The figure is the sum of the annual sales of the first and second generation G-CSF drugs, but Rolontis would compete directly against the second generation G-CSF drugs. The top-selling drugs are Neulasta (Kyowa Kirin Korea), Neulapeg (GC Pharma), Lonquex (Teva Handok) and Dulastin (Dong-A ST). A pharmaceutical market research firm IQVIA reported, the sales of these four second-generation G-CSF drugs have been steadily increasing since 2017, reaching about 46 billion won last year. Meanwhile, in the healthcare providers mostly predict, even if Rolontis is released in South Korea, highly unlikely the drug would dominate the market easily. The market size is relatively small, while already-commercialized products have stable presence in the medical field. Ultimately, the company would have to target the overseas market. Currently, the global market is estimated at 3 trillion won.
- Company
- Tagrisso expands benefits as a first-line treatment
- by Mar 24, 2021 05:45am
- Tagrisso, a targeted treatment for EGFR mutant non-small cell lung cancer, is not receiving benefits from the first-line treatment in Korea. The medical staff emphasized the need for Tagrisso's benefit. On the 19th, AstraZeneca Korea held an online press conference to commemorate the 5th anniversary of Tagrisso's postoperative adjuvant therapy acquisition and its launch in Korea. National Cancer Center’s Chief Researcher Ji-Yeon Han and Professor Min-hee Hong, Department of Oncology, Yonsei University Medical School, presented as speakers. Tagrisso, a third-generation EGFR TKI agent, started as a second-line treatment for EGFR mutant patients and acquired indications for the first-line treatment. Recently, it was used as an adjuvant therapy after surgery for patients with early stage (1B~3A) lung cancer among the first EGFR target treatments. Tagrisso is currently being used as a second-line treatment in Korea. This is because the most important insurance benefits are applied only to secondary treatment. This is in contrast to the insurance benefits applied to primary treatments in major countries around the world, such as the UK, the US, Japan, Germany, France, Italy and Switzerland. In recent years, in Canada, Russia, Australia, and Taiwan, benefits have also been expanded through primary treatment. The National Comprehensive Cancer Network (NCCN) also recommends Tagrisso the most (category 1) for the first-line treatment of EFGR mutant non-small cell cancer patients. In Korea, the results of sub-analysis on the Asian subgroup during the clinical trial of Tagrisso's FLAURA were controversial. Although the overall survival benefit was demonstrated in the entire global FLAURA patient population, the risk ratio (HR) of the Asian sub-analysis was 0.995. In fact, there was no difference from the control group, so there were opinions that there was no OS benefit for Asians. Accordingly, Chief Researcher Han Ji-yeon said, "One-third of the Asian subgroups were Japanese patients, which may have been due to different types of treatment than global ones." She explained, "In Japan, patients with recurrence after surgery, not general stage 4 lung cancer patients, were especially enrolled in the control group. Patients with recurrence after surgery are known to have a better prognosis than general stage 4 patients." Here, in the case of Japan, if there is any possibility of progressing to pneumonia, the drug is stopped immediately and there is a characteristic of switching to another drug. AstraZeneca admitted to the cross-over prescription of patients with confirmed T790M mutations in the first-generation drug from an ethical perspective, and taking this into account, it is encouraging to improve OS. Tagrisso is an EGFR TKI drug that has proven OS for more than 3 years in clinical practice. In a recent FLAURA China study of Chinese, OS showed a similar pattern to global clinical trials. Korea, which follows global treatment standards, will be similar. In particular, among other EGFR TKI agents, Tagrisso has the best BBB permeability, reducing the risk of disease progression or death due to central nervous system metastasis by 52%. One Chief Researcher explained, "The first principle in cancer treatment is to administer the most effective treatment to everyone first." "If Tagrisso resistance develops, there is no follow-up treatment option, so if it is used as a second-line drug, more than half of the patients who can actually be treated with Tagrisso will not have a chance. It is correct to use the best treatment for the first time." Professor Hong Min-hee also said, "From the point of view of the medical staff, the OS may be considered the most important part, but it is also very important for patients to live long and healthy. So, the primary evaluation indicators were disease-free survival (DFS) and progression-free survival (PFS)." Jin MYEONG, Managing Director of Korea AstraZeneca's anticancer drug business division, said, "We are sincerely discussing with the health authorities about the expansion of the primary benefits." We hope to make good progress." It is the first among EGFR TKIs, and it is very encouraging considering the cross-over prescription of a patient whose T790M mutation was confirmed in the first-generation drug for research ethics.
- Policy
- CMOs tense up for a full day MFDS investigation
- by Lee, Tak-Sun Mar 23, 2021 06:24am
- Set off by the Binex incident, South Korea’s Ministry of Food and Drug Safety (MFDS) has started a full investigation on pharmaceutical contract manufacturing organizations (CMOs). Although it was a day-long investigation, the companies noted it was pressuring. According to the relevant industry sources on Mar. 22, two to three regional MFDS branch officers in a group are investigating a single CMO a day. Compared against a regular Good Manufacturing Practice (GMP) inspection running three to four days, the special investigation was only a full day long. But all the investigated companies commented they felt the heavy pressure. Especially because the Criminal Investigations Office started digging into Binex and Vivozone accused of manufacturing products different from the approved label, which could not only lead to sales ban or recall order but also a judicial action, the investigated companies were apparently extremely tensed up. A medium-sized company associate said, “The staffs felt heavily pressured as the investigators knocked on the door unannounced. Even though the investigation was for a day only, we were worried of them finding some sort of an issue.” Regardless, there is no news of finding a new case. Some argue the investigation size is limited and finding the error based on document is extremely difficult. Another company associate said, “Apparently, the investigator chose one mass produced item and closely followed the manufacturing process. Generally, such investigation compares active pharmaceutical ingredient (API) inventory documents and the approved label to seek a possible difference. But it would be quite difficult to spot an issue within a company without a proper ERP management only based on the given papers.” However, the pharmaceutical companies are still keeping their guard up. They are concerned if any company among the 30 investigation subjects is found even with a miniscule problem, the investigation could open up to the entire pharmaceutical industry. The previous pharmaceutical company associate added, “Considering the negative public perception on the issue, MFDS could expand the investigation to target the whole of industry. The relevant companies would be greatly stressed to undergo the regular inspection and the special investigation.” On Mar. 12, Binex followed by Vivozone were found to have used different API from the approved manufacturing ingredient list, and MFDS began looking into 30 CMOs. Considering the inspection outcome, MFDS plans to revise the relevant system comprehensively to expand the inspection subject to include all pharmaceutical manufacturers and prevent the same violation.
- Company
- Domestic approval of Ajovy is imminent
- by Eo, Yun-Ho Mar 23, 2021 06:24am
- The second anti-CGRP mechanism following Emgality is expected to be approved in Korea. According to related industries, Teva Handok is in discussions for domestic approval of Ajovy(Fremanezumab), a migraine treatment targeting Calcitonin gene-related peptide (CGRP). Approval is possible within the first half of the year. The effectiveness of Ajovy in preventing migraine headaches was evaluated through two phase 3 placebo-controlled clinical studies in migraine patients who had difficulty in daily life, and proved the efficacy of reducing the number of migraine incidence days compared to the placebo group. As a result, Ajovy competes with Emgality (Galcanezumab) in the reimbursement and non-reimbursement market. Both drugs are humanized monoclonal antibody drugs that block binding to receptors by binding to the CGRP molecule, which plays a major role in triggering migraine symptoms in the brain. In the case of Ajovy, in addition to the once-monthly dosage form, it has a quarterly dosage form to improve medication compliance. It was approved by the European Commission (EC) in six months following the acquisition of marketing approval from the US FDA in September 2018. Emgality was launched in Korea in December 2019. Since no drugs have been registered, the process of insurance benefits is expected to be fierce. However, since CGRP is a relatively expensive drug, it is highly likely to be limited to at least tertiary therapy. However, since there are not many treatment options for migraine patients, the non-reimbursment market is also expected to be active. Shinchon Severance Hospital Neurology Professor Joo Min-kyung said, "Migraines are a pain that is more than expected and impair the quality of life of patients. Patients who experience migraine headaches more than 4-5 days a month can expect improvement in their quality of life through preventive treatment. CGRP drugs will be an encouraging option in situations where high blood pressure and epilepsy drugs have been recommended for preventive treatment." Last year, Emgality’s indications for reduction of headache attacks during cluster headache in adult patients suffering from cluster headache were expanded It occurs mainly in men in their 20s to 40s, and when the pain begins, it lasts for 15 to 180 minutes, and this pain occurs up to 8 times a day. Among them, patients who experience cluster headaches from 7 days to 1 year but experience painless periods for more than 3 months are classified as intermittent cluster headaches.
- Policy
- New benefits for Epidiolex will be established from April
- by Lee, Jeong-Hwan Mar 23, 2021 06:23am
- New standard for Epidiolex (a drug for refractory childhood epilepsy) will be established. Democratic Party of Korea Rep. Nam In-soon and others strongly pointed out the validity of health insurance benefits at last year's national audit. Epidiolex costs about ₩1.64 million per bottle, and up to ₩40 million per year. On the 17th, the MOHW announced an administrative notice of the amendment to the notification of details on the application standards and methods of medical care benefits. It is scheduled to be implemented from April 1 after collecting opinions by the 24th. In the revised bill, first, a new reimbursement standard for Cannabidiol (Epidiolex, CDB oil), a seizure treatment drug related to Lenox-Gasto Syndrome or Dravet Syndrome, will be established. Administration methods, administration targets, and evaluation methods are prepared within the scope of the approval of the MFDS. These patients were administered at a dose but did not show seizure reduction by more than 50% compared to the time of initial antiepileptic drug administration. It is administered in combination with Clobazam, and if it cannot be administered due to contraindications or side effects to Clobazam, it can be administered alone. Epidiolex is subject to the deliberation and resolution of the reimbursement list and benefit upper limit amount table of the Health Insurance Policy Deliberation Committee to be held in late March. Epidiolex is a drug that Democratic Party of Korea Rep. Nam In-soon repeatedly emphasized the validity and urgency of the benefit. At last year's inspection of the state administration, she said, "Epidiolex, which is a rare among pediatric epilepsy patients, is effective for patients with Travet syndrome or Lennox-Gasto syndrome, and is a drug that burdens children and parents because it is expensive." She pointed out that "there is a need for rapid promotion of health insurance coverage." In addition to Epidiolex, as Atorvastatin, a treatment for dyslipidemia, and Atmeg Combigel, a combination of omega-3, are scheduled to be listed, a new reimbursement standard will be established by referring to differences in license requirements from existing drugs. Atmeg Combigel is administered to complex dyslipidemia in which low-density lipoprotein cholesterol (LDL-C) levels are properly controlled with a single treatment of Atorvastatin 40 mg, but triglyceride (TG) levels are not controlled despite proper diet. The triglyceride level is 1 when side effects are expected when using an existing similar alternative drug (Fibrate or Niacin series) when blood TG≥500 mg/dL, risk factors or diabetes, blood TG≥200 mg/dL. 4 capsules per day are accepted. In addition, as the new vascular (wet) age-related macular degeneration drug Beovu Prefilled Syringe is scheduled to be listed, new standards such as administration targets and evaluation methods will be established. According to the newly established standards, the subjects of administration are patients with submacular choroidal neovascularization due to age-related macular degeneration, and cases of scarring or severe atrophy are excluded from administration. As for the administration method, if the treatment effect is not observed even after the initial three doses, subsequent administration is not recognized. In the case of using only one of Eylea and Lucentis, if there is no therapeutic effect after 3 times of administration after replacing with Beovu, subsequent administration will not be recognized as a benefit. From the 5th dose, if the corrected visual acuity is less than 0.1, no benefit is recognized. Concomitant administration with Visudyne (Vertporfin) is not recognized. The newly listed rheumatoid arthritis treatment Xeljanz XR Tab. 11mg (Tofacitinib) is admitted in accordance with the notification of the comparative drug reimbursement standard, but is revised in consideration of the difference in authorization.
- Policy
- “Regular COVID-19 vaccination like flu vaccination"
- by Kim, Jung-Ju Mar 23, 2021 06:23am
- The South Korean health authority says the COVID-19 vaccination could be periodically provided in the future, similar to an influenza vaccination, due to the pandemic still spreading strong around the world. It also means the health authority would have to successfully develop an mRNA vaccine platform, in which the government plans to soon announce an mRNA vaccine development support roadmap. At a regular COVID-19 briefing session convened on Mar. 19, Deputy Director Kwon Joon-wook of the Central Disease Control Headquarters talked about the plan. Deputy Director Kwon opened his statement saying, “As a part of the health authority and a president of Korea National Institute of Health (NIH), I feel the grave desperation to ensure South Korea to successfully develop a COVID-19 vaccine. And for a long-term purpose, the country has to develop an mRNA vaccine platform.” The deputy director elaborated, “The virus variant and antibody duration have to reviewed, but for now, the government sees that, like the annual influenza vaccination, the COVID-19 vaccination could be highly likely to be inoculated, although it may not be annually provided.” But the health authority faces a mountain of challenges to seek the vaccine. Besides the actual development of vaccine, the authority is burdened with unpredictable clinical trial execution, investment and virus variant, while it has not had sufficient experience in developing a vaccine. Deputy Director Kwon stated, “Regardless of all difficulties, currently, vaccine developing companies, researchers, experts, clinical institutes and all government bodies are combining focused effort to develop the vaccine. We may be struggling with a late start, slow speed, rough challenges and numerous variables, but we do not doubt that we would ultimately develop a South Korean-made vaccine or a better mRNA vaccine platform. To achieve the goal, the government would soon prepare and explain about the detailed support plan including an enterprise organization and a roadmap.”
- Company
- Who’ll be the 2nd Korean-made COVID-19 drug?
- by Kim, Jin-Gu Mar 23, 2021 06:23am
- Product image of Nafabeltan Chong Kun Dang’s candidate COVID-19 treatment Nafabeltan has failed to get the South Korean health authority’s conditional approval. As the Ministry of Food and Drug Safety (MFDS) shut the first door of conditional approval to highly anticipated candidate Nafabeltan, the public is now curious of who would be the next second South Korean-made COVID-19 treatment. Currently, the public highly anticipates of GC Pharma’s investigative plasma treatment. Also the anticipation on Bukwang Pharm, Daewoong Pharmaceutical and Shin Poong Pharm are heightening as well. ◆MFDS “Needs additional clinical trial,” Chong Kun Dang “Phase III clinical trial planned” On Mar. 17, MFDS announced the result of the COVID-19 Treatment Advisory Panel’s discussion on the candidate’s efficacy and safety. The Advisory Panel stated approving Chong Kun Dang’s Nafabeltan as a COVID-19 treatment, only based on the Phase II trial outcome would be inappropriate. They added it would need further clinical trial to be approved as a COVID-19 treatment. On Mar. 18, Chong Kun Dang announced its official position through an official statement. The statement explained, "The company has not received any official notification of the conditional approval rejection from MFDS. The related news would be officially announced immediately after the company receives an official notification." To this date in South Korea, Celltrion’s Regkirona (regdanvimab) was authorized as the first domestic COVID-19 treatment on last Feb. 5. After Celltrion snatched the honorable title first, the public started talking about Chong Kun Dang, GC Pharma, and Daewoong Pharmaceutical as the second domestically developed treatment. Among them, Chong Kun Dang was evaluated to be closest. In fact, Chong Kun Dang was the first of the three companies to apply for conditional approval to MFDS on Mar. 8. ◆GC Pharma “Approval application to be submitted in April,” while Bukwang, Daewoong and Shin Poong clinical trials well in process As the conditional approval on Chong Kun Dang’s Nafabeltan fell through for now, the interest of the pharmaceutical industry is again focused on the GC Pharma. Among all candidates of the second South Korean-made COVID-19 treatment, GC Pharma’s is considered to show the fastest progress. GC Pharma is developing a plasma treatment named, ’GC5131A'. On last Dec. 31, the company completed the administration of the drug on the Phase II participating patients. Currently, related data is being analyzed and organized. GC Pharma official said, "After completing data analysis within the first quarter, we plan to apply for approval to MFDS in April." The increasing cases of treatment-purpose use approval are also heightening the anticipation. According to MFDS, GC5131A has received approval for a total of 41 therapeutic uses since October last year. The public’s interest on Bukwang Pharm, Daewoong Pharmaceutical and Shin Poong Pharm is rising as well. Similar to Chong Kun Dang, the three companies are in process of repurposing an existing drug. Bukwang Pharm says that it is in the final stage of Phase II clinical trial. Bukwang Pharm is developing its own hepatitis B virus treatment, Levovir as a COVID-19 treatment. The Phase 2 clinical trial has completed administering 60 participants. Currently, the company is analyzing the gathered data for MFDS submission. Daewoong Pharmaceutical is repurposing a camostat-based chronic pancreatitis treatment Foistar as a COVID-19 treatment. The outcome of Phase IIa trial announced last year concluded the drug has statistically failed to meet the primary endpoint (cessation of viral shedding). However, the drug confirmed a meaningful improvement in symptom, which was a secondary end point. Based on the findings, Daewoong Pharmaceutical is currently conducting three cases of Phase IIb and Phase III trials—Phase II/III to evaluate Foistar’s efficacy and safety, Phase III to evaluate the candidate in combination with remdesivir and Phase III to evaluate the preventive effect against COVID-19. The specific plan for the approval application has not been disclosed. The company’s clinical trial protocol submitted to MFDS stated the trials would be done by coming December, but they could conclude earlier depending on the circumstances. Apparently, the company has not decided to apply for the full authorization after the Phase III trial is done, or for conditional authorization before completing the trial. Shin Poong Pharm plans to complete the Phase 2 clinical trial next month. Shin Poong Pharm’s trial is investigating the company’s malaria treatment, Pyramax, as a repurposed drug. The company announced that 76 out of 110 target patient size have been administered for Phase II trial as of Mar. 5. In order to expedite the progress of the remaining clinical trials, the company has added three clinical trial institutions to the existing 13.
- Policy
- The HIRA's reimbursed standards for chemotherapy are changed
- by Lee, Hye-Kyung Mar 23, 2021 06:23am
- The HIRA has changed the chemotherapy benefit standard, four criteria are changed and three criteria are deleted in relation to pancreatic cancer chemotherapy. Changes are made in a total of 25 criteria. The HIRA recently prepared an amendment to 'Details on the Standards and Methods of Applying Medical Care Benefits to Drugs Prescribed and Administered to Cancer Patients.' As a result, the standard for chemotherapy was improved sequentially, and the standard for chemotherapy related to small cell lung cancer, esophageal cancer, thyroid cancer, hepatobiliary cancer, and head and neck cancer was changed. The chemotherapy for which the reimbursement standard is changed this time is for pancreatic cancer, and the HIRA will conduct an opinion inquiry on the announcement (draft) of the drugs prescribed and administered to cancer patients by the 25th. The effective date is April 1. According to the announcement, the reimbursed standard was changed to 4 items and 13 therapies ▲location of group 1 anticancer drugs (3 therapy) ▲1. Change the phrase of the administration target for the postoperative adjuvant therapy no.1 (1 therapy) ▲2. Palliative therapy a. Administration stage: 'Gemcitabine + Paclitaxel (Albumin-bound)' combination therapy at the first stage 2. Palliative therapy b. Administration stage: Change the administration stage to 1st or more (1 therapy) ▲ 2. Palliative therapy b. At least one of the first steps in the administration phase, changes are made to the target phrases (8 therapy) from 1 to 8 times in a row. The elimination of the reimbursed standard is 3 items and 12 therapies ▲ Classification of group 1 and 2 anticancer drugs and deletion of the table of group 1 anticancer therapy (9 therapy) ▲ 2. Palliative therapy b. Administration stage: at least 1st (3 therapy) ▲2. Palliative therapy b. Dosing step: The first or more week 1 is deleted. The HIRA enacted the anticancer drug reimbursement standard in 2006, allowing clinicians to properly judge and administer Group 1 anticancer drugs within the general principles of approval and anticancer therapy announcements. They were classified as group anticancer drugs and used within the range of the reimbursed standard for each drug. However, opinions have been raised that reclassification of Group 2 anticancer drugs is necessary due to changes in drug prices, registration of generic drugs, and new listing of many high-priced anticancer drugs after the initial enactment. In addition, as clinical evidence is added every year due to the development of new drugs with new mechanisms, the necessity to check old public health therapies has emerged. Accordingly, the HIRA's subcommittee on Cancer Drugs Benefit Appraisal Committee has prepared a reorganization (draft) of reimbursed standards for related fields, and is preparing a new chemotherapy standard by removing the classification of group 1 and group 2 anticancer drugs through the process of collecting opinions from related conferences.
- Policy
- Pitavastatin-Ezetimibe by JW Pharmaceutical was applied
- by Lee, Tak-Sun Mar 22, 2021 06:18am
- JW Pharmaceutical is participating in the Statin-Ezetimibe hyperlipidemia complex market, which has more than 600 products in Korea. It is a combination of Livalo (Pitavastatin) and Ezetimibe. According to industry sources on the 21st, JW Pharmaceutical recently applied for permission for Pitavastatin-Ezetimibe to the MFDS. It was known as Livalozet. It will be the third Livaro series if approved. Livalo is a product jointly developed by Japan's Kowa and Nissan Chemical, and is being introduced and sold in Korea by JW Pharmaceutical. It received the first product approval in 2005, and since its launch in Korea, it has recorded high performance as an original Statin formulation. The amount of outpatient prescriptions based on UBIST last year amounted to ₩73.4 billion. Following Livalo's success, JW Pharmaceutical received approval in 2015 for the hyperlipidemia-hypertensive combination drug Livaro V, which combines Pitavastatin and Valsartan. Livaro V recorded an outpatient prescription of ₩8.2 billion last year. The most recent hyperlipidemia treatments include MSD's Vytorin (Simvastatin-Ezetimibe), Atozet (Atorvastatin-Ezetimibe), and Rosuzet (Rosuvastatin-Ezetimibe). Many generics for Atozet have been released,except for JW Pharmaceutical. While other pharmaceutical companies have focused on introducing Statin combinations, including Ezetimibe. However, JW Pharmaceutical has focused on Livalo (Pitavastatin). Clinical trials for the combination of Pitavastatin-Ezetimibe by JW Pharmaceutical began in 2017, and clinical trials have now been completed. Pitavastatin is known to have a lower risk of side effects of blood sugar compared to other Statins. Accordingly, it is attracting attention from the medical community in that it has a low risk of diabetes and shows excellent cardiovascular disease prevention effects. Because of these advantages of Pitavastatin, it is expected that the combination drug combined with Ezetimibe will be competitive if it comes to the market. There may be difficulties in settling the market as there are more than 600 Statin-Ezetimibe products on the market. It is noteworthy whether JW Pharmaceutical will be able to create a new cash cow item that succeeds Livalo's reputation.
- Company
- Big 5 to prescribe a novel antifungal drug Cresemba
- by Eo, Yun-Ho Mar 22, 2021 06:17am
- The Big Five South Korean general hospitals have registered a novel antifungal drug Cresemba for prescription. Pharmaceutical industry sources reported the Drug Committee (DC) at all of the Big Five general hospitals in South Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital and Severance Hospital, have recently passed Cresemba (isavuconazonium). However, the drug faces an issue with the healthcare reimbursement. In last year, the Health Insurance Review and Assessment Service (HIRA) internally revised the regulation on the pharmaceutical reimbursement subject evaluation standard and procedure. HIRA narrowed the scope of prospective subject for pharmacoeconomic (PE) analysis exemption, initially suggested as ‘antibiotics,’ to ‘antibacterials.’ Both the industry and academic scholars supported the government’s plan to expand the subject scope of the PE analysis exemption. But their definition of antibiotics was controversial. Medically speaking, an antibiotic means antimicrobial medicines that cover antibacterial, antifungal and antiviral. And the constant increase of antimicrobial resistance (AMR) is considered as the most critical public health risk around the world. Due to the major public health risk, some were disputing over unifying the definition of the new PE exemption subject—antibiotics—as ‘antibacterial’ based on the variant definitions of antibiotics. And the government sealed the deal by ‘limiting the exemption to ‘antibacterial’.’ Cresemba, categorized as an antifungal, is in shock of the government’s decision. Including South Korea, the number of fungal infection cases around the world has been surging as more than one million people are reportedly dying annually from fungal infection. However, the number of developed antifungal is limited. Among all fungal infection, the invasive aspergillosis is considered as one of three most deadliest invasive fungus to the human race. Even in Korea, the infection is counted as one of most frequent causes of death in patients with immune deficiency, due to increased number of patients receiving anticancer therapy and fighting against AIDS. President Choi Jung-hyun (Catholic University of Korea Eunpyeong St. Mary's Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “The risk of secondary nosocomial infection increases higher, when a patient with COVID-19-like severe disease is hospitalized for a long term or uses respirator for a long term. While the demand for securing sufficient amount of infectious disease drug is becoming ever more important to respond against novel infectious disease and secondary nosocomial infection, it is regretful that the government had to neglect the academic society’s advice and narrow down the definition of antibiotics.” In January last year, the Ministry of Food and Drug Safety (MFDS) has approved Cresemba, indicated to treat adult patients in age of 18 and older with invasive aspergillosis, and adult patients in age of 18 and older with mucormycosis for whom amphotericin B is inappropriate. With a wide variety targeted antifungal spectrum, Cresemba can treat both invasive aspergillosis and invasive mucormycosis. The drug is currently the only azole antifungal in South Korea indicated for invasive mucormycosis.
