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- 2026-04-15 15:34:46
- Company
- Gilead on its way to introduce HCV drug Epclusa in Korea
- by Eo, Yun-Ho Feb 23, 2021 06:11am
- Gilead is finally showcasing another pipeline for hepatitis C virus infection. The pharmaceutical industry source reported Gilead Science Korea has submitted an application for the South Korean health authority’s approval on a pan-genotype hepatitis C virus (HCV) infection treatment Epclusa (sofosbuvir/velpatasvir) to be used on an adult patient with chronic HCV infection, regardless of liver cirrhosis. Epclusa is a fixed-dose combination drug consisting of 400 mg of Sovaldi (sofosbuvir), authorized by the U.S. Food and Drug Administration (FDA) in 2013, and 100 mg of a nonstructural protein 5A (NS5A) inhibitor velpatasvir. The combination drug can be administered once-daily in combination with ribavirin for patients with moderate to severe decompensated liver cirrhosis patients. Even without interferon, 12-week treatment of the drug can show close to 90 percent response rate. Three of ASTRAL clinical trials conducted with 1,558 patients with all six hepatitis C genotypes without cirrhosis or with compensated cirrhosis found 95 percent to 99 percent of patients using Epclusa achieved sustained virologic response at week 12 (SVR12). 87 patients with moderate to severe HCV infection in the ASTRAL-4 trial reached a high SVR12 rate of 94 percent, while the most common adverse reactions were headache and fatigue. Although the treatment for genotype 2 and 3 HCV infection used to be complicated, now Epclusacan be used regardless any genotype, as does AbbVie’s Mavyret (glecaprevir/pibrentasvir). The focus of HCV infection treatment seems to leaning towards pan-genotype treatment. The World Health Organization’s (WHO) latest HCV infection treatment guideline recommends using pan-genotype treatment like Mavyret, which does not require further examination.
- Company
- Competition between Soliris & Enspryng is predicted in Korea
- by Eo, Yun-Ho Feb 23, 2021 06:11am
- Competition between two expensive drugs is expected in the field of Neuromyelitis Optica Spectrum Disorder Aggravate (NMOSD) According to related industries, Roche's Enspryng (Satralizumab) is in the process of domestic approval, while Handok's Soliris (Eculizumab) recently added an indication for optic neuromyelitis. Soliris has been used only as a treatment for paroxysmal nocturnal hemoglobinuria (PNH), but the indication has been expanded. Enspryng is currently competing with Soliris in the United States, and is attracting attention because It is attracting attention because it is cheaper than Soliris. Alexion, developer of Soliris, added an indication for NMOSD in the United States last June. However, it is not known how long it will take for both drugs to apply insurance benefits. Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare relapsing autoimmune disorder that preferentially causes inflammation in the optic nerve and spinal cord. Since there is no clear treatment so far, high-dose steroids are generally used, and immunoglobulins, a blood product, are administered to severely ill patients, or plasma separation is performed. Soliris demonstrated efficacy in preventing the risk of relapse of optic neuromyelitis. 97.9 percent of patients receiving Soliris were relapse-free at 48 weeks compared with 63.2 percent of patients receiving placebo. New data published in NEJM and to be presented for the first time at the AAN meeting confirm that the significant relapse reduction observed in the PREVENT study was sustained through three years of treatment. This approval is supported by results from two randomized controlled Phase III clinical trials, the SAkuraStar and SAkuraSky studies, in which Enspryng demonstrated robust and sustained efficacy and a favorable safety profile in adults with AQP4 antibody positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody positive subgroup, 76.5% of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with baseline IST, 91.1% of Enspryng-treated AQP4 antibody positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
- Policy
- Antidiabetic drug GLP-1 RA to be recommended for NASH
- by Lee, in-bok Feb 23, 2021 06:11am
- The use of antidiabetic drug is to be expanded in treating non-alcoholic steatohepatitis (NASH) as the Korean Association for the Study of the Liver (KASL) gave a priority recommendation on prescription of pioglitazone. The prospective prescription strategy is likely to see a significant change as a glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, becoming a star obesity drug with exceptional weight-loss effect, has emerged as a new key treatment option. # On Feb. 17, KASL convened an online hearing session to revise the NASH treatment guideline and unveiled the first draft of the revision scheduled to be published on Mar. 5. The guideline would vastly revise the year 2013 edition of NASH treatment guideline for the first time in nine years. The association formed a revision committee last year and held eight sessions of meeting focusing on seeking an evidence-based guideline. The amended version of the guideline would specify the pharmaceutical therapy in detail, when in 2013 the guideline was published with a simple description. Many of the drugs that accumulated evidences through clinical trial and meta-analysis so far were addressed in the new version. Most of the pharmaceutical therapies recommended by the new guideline were antidiabetic treatments—pioglitazone, metformin and semaglutide. First, the guideline recommends administering pioglitazone for treating patients with biopsy-confirmed NASH regardless of underlying diabetes, based on four large-scale studies, including the randomized study published in the New England Journal of Medicine (NEJM) in 2015, proving efficacy of the substance. The evidence level is B1. However, the guideline also noted a condition to the prescription that the prescriber should be aware of the benefit and risk of the drug as the large-scale randomized study warned of safety issues regarding adverse reaction reported during a long-term prescription. And for the same reason, metformin was also recommended by the latest guideline with the efficacy in NASH treatment confirmed by a randomized controlled trial that found a six years or more long-term prescription of the drug lower mortality, liver transplant and hepatocellular carcinoma expression rate in patients diagnosed with NASH and liver fibrosis. Moreover, the newest version of the guideline approved of a GLP-1 RA semaglutide as a priority recommendation. A 72-week Phase II trial with NASH patients observed the drug stopped the fibrosis worsening by 40 percent with 0.1mg dose. Professor Kim Won of Seoul National University School of Medicine specializing in Internal Medicine evaluated, “Semaglutide seems to show efficacy in treating NASH based on its outstanding weight-loss rate.” However, other drug like Saxenda (liragultide), also known for the notable weight-loss effect, was not included in the guideline. The association concluded, liraglutide showed efficacy of improving insulin resistance (IR) and lowering the cardiovascular risk factors, but they were limited in treating diabetes and obesity, and medical evidence relevant to NASH is insufficient. In the revised draft of the guideline, KASL also added a statin prescription strategy considering the high mortality rate by cardiovascular disease in NASH patients. In fact, in the GREACE study, statin significantly improved the reduction of the expression of cardiovascular disease in NASH patients, who have increasing liver enzyme concentration. And another clinical trial conducted in South Korea also confirmed the same efficacy. The head of the treatment guideline revision committee, Professor Cho Yong Kyun (Sungkyunkwan University School of Medicine) noted, “We also reviewed SGLT-2 inhibitor lowering body weight and carnitine combination therapy improving the antioxidant activity, but we could not find enough clinical data regarding the treatment of NASH to be included in the guideline.”
- Policy
- Weighted average price of α-GPC, ₩512
- by Lee, Hye-Kyung Feb 22, 2021 06:18am
- The weighted average price of Choline alfoscerate 0.4g, which was the subject of reevaluation of the adequacy of benefits last year, decreased 0.2% from the previous year to ₩512. The weighted average price of Vitis vinifera 50mg. and Avocado-Soya unsaponifiables 0.3g, which are undergoing re-evaluation this year, decreased by 1.7% and 5.3%, respectively, compared to the previous year. Dailypharm recently revealed this trend as a result of calculating the low-dose weighted average price of major ingredients over the last three years based on the '2020 yearly weighted average price of drug per year' that the HIRA recently released. The data released this time was calculated as a weighted average price of 3, 554 ingredients for health insurance review in the previous year for items listed on the drug benefit list as of February 1 of this year. The weighted average price of each major ingredient was reduced by 2.9% for Donepezil 10mg, a dementia treatment drug, from ₩1,971 in 2019 to ₩1,941 in 2020. The weighted average price of Amlopidine besylate 5 mg, a hypertension drug, was calculated last year at ₩358 (-0.3%), and the average price of the combination drug Amlodipine besylate 10 mg/ Telmisartan 80 mg was calculated at ₩845 (-0.7%), and The average price of Amlodipine besylate/Valsartan 80mg was calculated as ₩982 (no change). The price of Ezetemib 10mg/Rosuvastatin 5mg, a combination treatment for hyperlipidemia, was cut last year to ₩883 (-0.3%), and the price of Clopidogrel was reduced to ₩1,118 (-0.9%). The weighted average price of Ginkgo leaf dried extract 0.12g last year was ₩110, the weighted average price of Bilberry dried extract 0.17g was ₩238, and the weighted average price of Silymarin 0.35g was ₩401, the same as the previous year. The weighted average price by active ingredient is used as a reference price when preparing drug economic evaluation data or negotiating drug prices. The weighted average price released this time was excluded from calculation when there was no billing performance last year, when the upper limit price could not be calculated or Amino acid preparation. The same ingredient, same formulation, and same dosage were calculated by weighted average value with the same main ingredient. The formulation code was TB·CH·CS as TB, CE·TE as TE, CR·TR as TR, and GN·PD is calculated as GN, CM·OM·PA as OM, PC·PL·PO as PL, and SY·SS as SY. In the case of product code changes due to transfer, the amount of claim for the item before the change is incorporated into the item after the change. For patent-related items, the upper limit of the item is calculated as a weighted average price.
- Company
- Dupixent to treat pediatric patients with atopic dermatitis
- by Eo, Yun-Ho Feb 22, 2021 06:17am
- The use of atopic dermatitis and asthma treatment Dupixent (dupilumab) could be expanding also in South Korea to be administered to children. A pharmaceutical industry source reported Sanofi Genzyme has submitted an indication expansion application last year on Dupixent to be indicated for a ‘treatment in pediatric patients aged six through 11 with severe case of atopic dermatitis and underlying condition of various type 2 inflammations,’ and a ‘treatment in patients with type 2 inflammatory asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).’ The approval decision would be made within the first quarter of the year. A Phase III trial has reportedly confirmed the efficacy of Dupixent and topical corticosteroids (TCS) combination therapy in treating pediatric patients with atopic dermatitis. The trial found the Dupixent combination group showed average 82 percent improvement from baseline in disease extent and severity, when administered every four weeks, compared to 49 percent improvement in placebo group. Also for other indicators like skin itchiness and clearance, the combination therapy performed improved efficacy compared against TCS alone. Even if the health authority approves of the additional indications, it is unclear how long it would take to expand the National Health Insurance (NHI) coverage. Dupixent was authorized for sales in South Korea in March 2018, and it was listed for NHI reimbursement in January 2020 after submitting the application in February 2019. Expanding the indication for pediatric patient would increase the usage significantly that the health authority and the applicant company would have to reach a difficult agreement for the coverage expansion. Since January 2021, Dupixent was applied with a special case coverage for treating severe level of atopic dermatitis, bringing down the patient copayment rate from 60 percent to 10 percent. Up until then patients paid about 12 million won for administering 27 doses per year at a tertiary hospital, but now with the special case coverage, the patients would only have to pay 2 million won annually.
- InterView
- Genexine Licenses out immuno-cancer Drug Technology
- by Kim, Jin-Gu Feb 22, 2021 06:17am
- Genexine announced on the 18th that it has signed a technology transfer contract worth ₩1.2 trillion with KG BIO, a subsidiary of Indonesian pharmaceutical company Kalbe Farma, for GX-17, an immune anticancer drug candidate. KG BIO is a joint venture established in 2016 by Kalbe Farma, the largest pharmaceutical company in Southeast Asia, and Genexine. Under this contract, KG BIO took over the copyright of GX-17 to ASEAN countries, the Middle East, Australia, New Zealand, India and Africa. The down payment is $27 million (approximately ₩30 billion), and additional milestones that can be received according to phased schedules such as clinical progress, approval, and commercialization are $1,073 million. Separately, it was decided to receive 10% royalties when GX-17's sales were generated. KG BIO is said to be owned by Kalbe Farma (64%), Genexine (20%), and US investor General Atlantic (15%). GX-17 is a candidate substance for Genexine's anticancer drug. In phase 1b·2 clinical trials conducted in combination with Keytruda, another anticancer drug last year, the objective response rate (ORR) was 5 times higher than that of Keytruda.
- Policy
- Central Committee conflicted over Rekirona limits use
- by Lee, Tak-Sun Feb 22, 2021 06:17am
- Apparently, the Central Pharmaceutical Affairs Deliberation Committee has reached a conclusion after an intense discussion in approving of Celltrion’s COVID-19 monoclonal antibody treatment Rekirona, conditionally authorized for use on Feb. 5. The Central Pharmaceutical Affairs Deliberation Committee was convened for a meeting on Jan. 27 and advised Rekirona to be conditionally used on high-risk patients with mild COVID-19 symptoms and patients with moderate symptoms. The indication was actually narrowed from the COVID-19 Treatment Advisory Panel’s previously opinion that the treatment can be used without a limitation in patients with mild to moderate symptoms. In the Central Committee meeting minute disclosed on Feb. 18, many have raised concerns of using the drug for patients with mild symptoms and the opinions were vastly split. Total 18 of experts and five Ministry of Food and Drug Safety (MFDS) officials participated in the meeting held on the day. A committee member proposed a conditional approval, as “the clinical recovery as of Feb. 14 confirmed the meaningful efficacy. The applicant targets patients with mild to moderate symptom, but the submitted evidence showed statistical improvement of the symptoms only in patients with moderate symptoms (40 mg/ kg) among overall patients with mild and moderate symptoms and age 50 and over patients with moderate level of symptoms.” Another committee member recommended, “As an advisor, I can see the data confirming the improvement in patients with mild symptoms, but considering it would be an expensive drug, shortening the time to recover by a few days in the mild condition patient would not be meaningful, clinically speaking.” However, Celltrion refuted shortening the time to recover in mild condition patient is a meaningful outcome. The company official was connected via video conference call during the meeting and said, “As far as the symptom improvement goes, the efficacy in patients with mild symptoms is comparatively lower than in patients with moderate symptoms, but still the time to recover was reduced. It would be beneficial to the patients with mild condition to lessen the number of recovery days, too.” The official also told the company aims to complete registering 1,172 participating COVID-19 patients in April through May for the Phase III clinical trial. Some also urged the agenda should be revisited when more data is collected from the Phase III trial. A committee member advised, “Rather, it would be more appropriate to grant a limited approval for patients with underlying condition of pneumonia, who could develop the symptoms worse. The definite decision should be made after re-discussing about the drug, when it comes back with sufficient Phase III trial data.” Rekirona injection, in fact, has caused a conflict already, when the company presented the Phase II trial outcome. Among the primary efficacy endpoints, the drug demonstrated statistically meaningful improvement in clinical recovery only, while the drug did not achieve another satisfactory endpoint, the virus shedding time. A MFDS official participating at the meeting commented, “Some Phase III trials designed with multiple primary endpoints confirm the efficacy when two endpoints are achieved. But this Phase II trial was not designed as a multiple testing.” “Comparing the two endpoints, the clinical recovery seems to be more valuable endpoint, which was met. The virus shedding endpoint was not met as expected, but the drug could have shown the mechanism of shedding the virus as patients’ level of virus demonstrated the descending tendency with the drug administration,” the official added. However, some even urged they can hardly support the idea of conditional approval as the secondary endpoints, such as hospitalization, oxygen therapy, and decrease in death rate, were not able to verify properly, let alone the primary endpoints. One of the members also noted, “The current data is only sufficient for an emergency use authorization than a conditional approval,” and some others agreed. Rekirona injection earned the authorization on Feb. 5 with a condition to provide Phase III clinical trial data. In accordance to the Central Committee’s recommendation, the drug is indicated to be used on high-risk COVID-19 patients with mild symptoms, or patients with moderate symptoms (age over 18) to improve their clinical symptoms. The high-risk patients with mild symptoms are limited to patients aged over 60 or having one of underlying conditions (cardiovascular disease, chronic respiratory disease, diabetes or hypertension). On Feb. 17, Rekirona injection started supplying to healthcare institutes in South Korea.
- Policy
- Ninlaro for multiple myeloma & Lutathera are listed
- by Lee, Hye-Kyung Feb 22, 2021 06:17am
- The standard of benefit of Ninlaro (Ixazomib Citrate), combination therapy for multiple myeloma and Lutathera (Lutetium Oxodotreotide) for neuroendocrine cancer will be established. The HIRA announced that it is proceeding with the amendment of the announcement according to drugs prescribed and administered to cancer patients and will receive comments by the 23rd. It will be applied from the 1st of next month. Ninlaro is a drug approved for combination therapy with Lenalidomide and Dexamethasone in the treatment of patients with multiple myeloma who have previously received more than one treatment. According to the textbook review, Ninlaro is mentioned as an oral drug in the PI (proteasome inhibitor) family. In the NCCN guidelines, combination therapy of Ninlaro, Lenalidomide & Dexamethasone is recommended as Category 1 for the treatment of multiple myeloma that has been previously treated, and as 'I, A' in the ESMO guidelines. As a result of comparing Ninlaro/Lenalidomide/Dexamethasone with Lenalidomide/ Dexamethasone in a randomized phase 3 clinical trial (TOURMALINE-MM) in multiple myeloma patients with previous treatment experience, the median progression-free survival was 20.6. months vs. 14.7 months, and the overall response rate was 78.3% vs. 71.5%. As both Lenalidomide and Dexamethasone are taken orally, the effect was improved compared to the control group, so the supplement standard was newly established. On November 17, 2019, Lutathera was recognized as an emergency drug by the MFDS for the treatment of adult patients with advanced and metastatic somatostatin receptor-positive gastrointestinal tract and pancreatic neuroendocrine tumors that are not resectable and highly differentiated. As a result of reviewing textbooks, guidelines, and clinical papers by the HIRA, Lutathera is a clinically useful and medically necessary drug and has been listed as a monotherapy for neuroendocrine cancer 3rd, 4th or higher. However, IV infusion is possible up to 4 times in consideration of the evidence of related clinical literature. It was set to 3rd-4th steps, reflecting the opinions of experts and the society that it is quite expensive compared to alternative drugs and that realistic standards appropriate to the Korean situation are needed.
- Policy
- AstraZeneca's vaccine, lot release for 780,000 people
- by Lee, Tak-Sun Feb 22, 2021 06:17am
- All administrative procedures for AstraZeneca's COVID-19 vaccine, scheduled for vaccination on the 26th, have been completed. The final step was approved by the MFDS. The MFDS announced that it had national lot release of 787,000 people (1,574,000 doses) of AstraZeneca's COVID-19 vaccine applied on the 29th of last month on Wednesday. This approval was carried out quickly in 20 days, the national lot release usually takes 2-3 months and it is expected to be used for the first domestic COVID-19 vaccine vaccination from February. National lot release is a system in which the country checks the quality of vaccines once more before distribution to the market by comprehensively evaluating the results of the qualification test for each manufacturing unit (lot) of the vaccine and the data review that produced and tested the results as permitted by the manufacturer. AstraZeneca's COVID-19 vaccine is a quantity manufactured by consigning all processes from SK Bioscience. In preparation for the concentration of applications for national lot release of COVID-19 vaccine, the sample storage room was expanded and additional storage freezers were secured. For national lot release, the MFDS confirmed the safety and effectiveness of each manufacturing unit through a verification test of 1,574,000 batches and a review of data on manufacturing and testing. As for the assay, AstraZeneca's COVID-19 vaccine was a viral vector vaccine and conducted a sterility test and a bacterial endotoxins test for safety, and confirmed that there was no contamination of microorganisms such as bacteria during the manufacturing process of the vaccine. Regarding the effectiveness, a potency test and a viral vector content test were conducted to measure the amount of protein expression effect, the maintenance of the desired genetic material, and the amount of the vector as a genetic material delivery. In addition, properties tests, pH measurement tests, and actual dose tests of syringe injections were conducted as general vaccine quality test items. The MFDS explained that as a result of reviewing detailed information and manufacturing and quality control records related to vaccine raw materials, undiluted solutions, and finished drugs, it was in compliance with the drug manufacturing and quality control standards (GMP) and approved matters. In addition, manufacturing and storage information, test methods, test standards, and results were confirmed by each stage of the manufacturing process, including information on the history of cell lines and virus lines used as vaccine materials. The MFDS emphasized that it will do its best to ensure that the Korean people can receive the vaccine by thoroughly verifying COVId-19 vaccine introduced in Korea by making full use of the professional manpower and equipment-related infrastructure required for national lot release.
- Company
- Talks on expanding coverage on Tecentriq to start soon
- by Eo, Yun-Ho Feb 19, 2021 06:17am
- An immunotherapy Tecentriq (atezolizumab) is to face the first threshold to expand the National Health Insurance (NHI) reimbursement in treating patients with either triple-negative breast cancer (TNBC) or hepatocellular carcinoma. A pharmaceutical industry source reported the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee would be convened on Feb. 24 to deliberate Roche Korea’s programmed death-ligand 1 (PD-L1) inhibiting immunotherapy Tecentriq seeking to expand reimbursement on indication to treat patients with TNBC and hepatocellular carcinoma. Last year, Tecentriq, in combination with nanoparticle albumin-bound (nab) paclitaxel, won the South Korean health authority’s approval to treat patients with TNBC as a first-line treatment, and it also earned an approval to treat liver cancer as a first-line treatment through Avastin (bevacizumab) combination therapy. Once it successfully expands its coverage, Tecentriq would be the first immunotherapy option for the two cancer types. However, it is still unknown what decision the Cancer Deliberation Committee would make. Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government as the company accepted the condition to cover the initial administration cost. However, Roche has not commented if it would take the same condition for the expanded coverage. The two indications barely had any treatment option and an emerging option of an immunotherapy heightened the interest of medical academics. As far as the possibility goes, the TNBC indication would be more likely. Only 12 percent of patients diagnosed with breast cancer are specifically diagnosed with TNBC, and only a half of the particular patient group would consider Tecentriq option (PD-L1 expression rate is over 1 percent). Relatively small patient size would cause less financial burden. Moreover, TNBC is mostly diagnosed in young and socially active patients younger than 40, which causes high socioeconomic cost from faltering labor, productivity and childcare activities. Accordingly, the coverage on Tecentriq combination therapy could favorably contribute in reducing the social cost in long term. To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet. In the IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. In the same patient group, the Tecentriq combination therapy achieved the median overall survival (mOS) at 25.0 months. Professor Im Seock-ah at the oncology department of Seoul National University Hospital said, “The Tecentriq combination therapy demonstrated a meaningful improvement in PFS and mOS longer than two years in patients with metastatic TNBC. We can anticipate the treatment option to be a crucial turning point in treating metastatic TNBC with high unmet medical needs.” Meanwhile, the efficacy of Avastin combination therapy treating patients with hepatocellular carcinoma was confirmed in the IMbrave150 study. The result found the patient group using Tecentriq in combination with Avastin reduced the risk of disease worsening or death by 41 percent, compared with Nexavar (sorafenib) patient group. The Tecentriq plus Avastin therapy was also confirmed superior than Nexavar therapy as the combination therapy group’s mPFS marked 6.8 months, which was significantly longer than Nexavar group’s 4.3 months. The combination therapy has not reached the mOS, but the median value during the monitoring phase was at 8.6 months. Nexavar had mOS of 13.2 months. Also the combination therapy’s response rate at 27 percent doubled Nexavar therapy’s at 12 percent. Professor Kim Doyoung of Gastroenterology Department at Severance Hospital noted, “Beside the OS, the improvements in the response rate and PFS were positive findings. We are glad to have found an immunotherapy option in the liver cancer area that has no other alternative than Nexavar. Hopefully, the drug can meet the highly unmet medical needs in the future.”
