- LOGIN
- MemberShip
- 2026-03-16 21:30:23
- 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.
- Company
- Emergency Contraception (EC) monopolized by Hyundai
- by Oct 11, 2022 05:50am
- As generics enter the Emergency Contraception (EC) market, which is dominated by Hyundai Pharmaceutical, a maximum of five-way race is expected. Generics that avoided patents led by GL Pharma predicted full-scale sales this month. According to the pharmaceutical industry on the 8th, Arlico Pharmaceutical, The U, GL Pharma, and Kwangdong Pharmaceutical will release EC containing Ulipristal ingredients this month. They obtained an item license from the Ministry of Food and Drug Safety in June last month. All are generics of Hyundai Pharmaceutical's Ellaone, and GL Pharma is in charge of producing all four products. GL Pharma was the first to obtain generic for Ellaone and then recruited companies to launch the generic together. In the process, the U, Arlico, and Kwangdong joined. GL Pharma filed a passive judgment in December last year on Ellaone's patent for Ulipristal after successfully developing a formulation that avoided the scope of Ellaone's patent. When the Korean Intellectual Property Tribunal cited the plaintiff's claim on September 14, not only GL Pharma but also three pharmaceutical companies that participated in the consignment secured generic for exclusion. Ellaone is an original ingredient of Ulipristal and was developed by French pharmaceutical company Laboratoire HRA Pharma and introduced by Hyundai Pharmaceutical in Korea. It currently generates the largest sales in the oral contraceptive market. Last year's sales amounted to 3.3 billion won. Norebwon (Levonorgestrel), is following with 2.2 billion won. The Emergency Contraception (EC)) market is largely divided into two active ingredients: Levonorgestrel and Ulipristal. Among the Levonorgestrel ingredient emergency contraception (EC) market, Hyundai Pharmaceutical exclusively occupied the Ulipristal ingredient. Hyundai Pharmaceutical's Ellaone patent expires in 2029. However, as GL Pharma succeeded in avoiding the scope of Ellaone patents last month, it advanced the release of generics by about seven years. From the fourth quarter of this year, GL Pharma is expected to be the biggest beneficiary when the Ulipristal market enters the generic competition system. GL Pharma is a pharmaceutical company specializing in sex hormone drugs and has been researching, producing, and supplying various contraceptives and sex hormone drugs over the past four years.
- Company
- The second CGRP migraine drug Ajovy's benefit is listed
- by Eo, Yun-Ho Oct 11, 2022 05:50am
- According to related industries, Handok Teva has begun negotiations with the HIRA on the drug price of Ajovy, a target migraine treatment for Calcitoningenene-related peptide (CGRP). Ajovy passed the HIRA Drug Benefit Evaluation Committee last month. Ajovy's drug price is expected to be negotiated as its competitive drug and first item, Emgality, was applied in September. If Ajovy succeeds in registering, competition for the prescription of the two drugs is expected to begin in earnest. Emgality and Ajovy are the same category of drugs, but there are differences in dosage, so they are being selected according to the characteristics of severe migraine patients. Emgality is administered 240 mg (two consecutive subcutaneous injections each of 120 mg) once at a loading dose, and then subcutaneous injections of 120 mg once a month. Ajovy 225 mg is used once a month or 675 mg (three consecutive times of 225 mg) is injected subcutaneously once every three months. Ajovy proved its validity through a 12-week HALO EM/CM clinical trial in 2,000 EM and CM patients. In a HALOEM study conducted to verify the efficacy and safety of Ajovy compared to the placebo group, Ajovy was evaluated to meet the primary evaluation variable by significantly reducing the number of monthly migraine occurrences in both monthly and quarterly administration groups. The proportion of patients whose average monthly migraine days decreased by more than 50% was also higher in the Ajovy monthly administration group and 44.4% in the quarterly administration group compared to 27.9% in the placebo group. In the HALOCM study, the average number of monthly headache reduction days in the Ajovy administration group was 4.6±0.3 days, and the quarterly administration group was 4.3±03 days, which was significantly reduced compared to 2.5±0.3 days in the placebo group.
- Company
- Only 2 out of 10 are prescribed monotherapy for diabetes
- by Kim, Jin-Gu Oct 07, 2022 06:04am
- The use of combination therapies in diabetes has been increasing further. Already, 8 of 10 patients are prescribed two or more drugs at once. In particular, the triple therapy combination regimen seems to be rapidly establishing its presence in the field. By ingredient, DPP-4 inhibitor class drugs are still showing strength, but their growth is gradually slowing down. On the other hand, SGLT-2 inhibitor class drugs are gaining influence, while sulfonylurea class drugs are on a steady decline. ◆From dual to triple therapies…the diabetes treatment paradigm is shifting The Korean Diabetes Association published a ‘2022 Diabetes Fact Sheet’ that contained the information above. Based on the national health insurance claims data, the Fact Sheet contains the prevalence, treatment rate, and drug prescription rate of diabetes in Korea from the year 2002 to 2019. Present status of Oral Hypoglycemic Agent combination therapies (Data: 2022 KDA Diabetes Fact Sheet) According to the data, the prescription rate of monotherapy in diabetes was 22.2% in 2019. 2 in 10 diabetes patients have been prescribed a single drug for their condition. The other 77.8% are receiving two or more drugs at once. The rate of combination therapy prescriptions had risen 5.4%p in 5 years from the 73.4% in 2014. In particular, the prescription rate of three-or-more drug combinations is on the rise. The three-or-more drug combination therapies that had been prescribed in only 31.9% of all cases until 2014, had risen 6.1%p in 5 years to 38.0%. In the same period, prescription of dual combination therapies had decreased by 1.7%p from 41.5% to 39.8%. Prescription of monotherapies had fallen 4.4%p in 5 years from the 26.6%. The gap between prescription of dual and triple combination therapies had been 9.6%p in 2014, which had been reduced to 1.8% in 5 years. The industry has been interpreting this as a shift in the diabetes treatment paradigm, of how the diabetes treatment paradigm is moving from dual combination therapies to triple combination therapies. This phenomenon is also reflected in the number of drugs that are initially prescribed after being diagnosed with diabetes. First drug prescription for diabetes after diagnosis (Data: 2022 KDA Diabetes Fact Sheet) In 2009, 66.7% of the patients first diagnosed with diabetes were prescribed monotherapy. The prescription rate of dual combination therapies had been 30.6%, and triple combination therapies 2.7%. In 2019, the prescription rate of monotherapies in those first diagnosed with diabetes had become 58.9%, a 7.8%p decrease in 10 years. On the other hand, the prescription rate of dual combination therapies had increased 4.9%p to 35.5%, and triple combination therapies 2.9%p to 5.6%. ◆Sales of metformin and DPP-4i surge... sulfonylurea sales fall, SGLT-2i rise By ingredient, metformin and DPP-4 inhibitor class drugs are still the most popular. As of 2019, 87.5% of all diabetes patients were prescribed metformin, followed by 63.9% receiving DPP-4 inhibitor class drugs, 41.7% sulfonylurea (SU), 11.6% TZD class, 10.8% SGLT-2 inhibitor class, 8.4% insulin (duplicate prescriptions reflected in the statistics). Compared to 5 years ago in 2014, the prescription rate of metformin increased by 2.1%p from 85.4% to 87.5%. In the case of DPP-4 inhibitors, prescriptions increased by 18.5%p from 45.4% to 63.9% in the same period. After it was first introduced in 2008, the prescription of DPP-4 inhibitors increased rapidly to reach 59.1% in 2016. However, since then, its growth slowed to 61.8% in 2017, 63.4% in 2018, and 63.9% in 2019. Analysis of prescription patterns by diabetes drug ingredient (Data: 2022 KDA Diabetes Fact Sheet) In the case of sulfonylurea, sales are on a constant decline. Although it had been the most-prescribed drug until 2009, the prescription rate of sulfonylurea started to slow down with the introduction of DPP-4 inhibitors. Due to this the prescription rate of sulfonylurea class drugs, which had reached 75.8% in 2009, fell to 51.2% in 2015, and then was overtaken by sales of DPP-4 inhibitors. Sales continued to decrease further to 41.7% in 2019. On the other hand, SGLT-2 inhibitor class drugs have been rapidly increasing their influence since their introduction in 2014. Their prescription rate, which had been only 2.4% in 2015, rose to 10.8% in 2019.
- Company
- Lilly prepares to introduce Olumiant for hair loss in Korea
- by Eo, Yun-Ho Oct 07, 2022 06:04am
- JAK inhibitors may soon be prescribed to treat hair loss in Korea as well. According to industry sources, Lilly Korea is preparing to apply and expand the indication for its JAK inhibitor Olumiant (baricitinib) to severe alopecia areata to the Ministry of Food and Drug Safety. After the drug was approved in June for the indication by the US FDA, the company is quickly entering global commercialization. Olumiant selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and demonstrates an overall anti-inflammatory effect. It was first approved as a treatment for rheumatoid arthritis, then expanded its indication to atopic dermatitis in Korea and some other countries. In the US, Olumiant is also prescribed to treat hospitalized COVID-19 patients. Alopecia areata is also an autoimmune disorder that causes the body to attack its own hair follicles, resulting in hair falling out. In addition to scalp hair, eyebrows and eyelashes can also fall out. The efficacy of Olumiant in severe alopecia areata patients was demonstrated through the company’s BRAVE-AA1 and BRAVE-AA2 trials. The two trials evaluated the safety and efficacy of Olumiant in 1,300 patients compared with a placebo. In the AA1 trial, 22% of the 184 patients that took Olumiant 2mg, and 35% of the 281 patients that took Olumiant 4mg showed an appropriate level of scalp hair coverage and achieved a Severity of Alopecia Tool (SALT) score of 20 or less. The rate was only 5.3% in the placebo arm. The higher the SALT score, the more severe the degree of hair loss is considered to be. 31% and 35% improvements in eyebrow and eyelash coverage were also observed in the Olumiant 2mg and 4mg arm, respectively. In the AA2 trial, 17% of the Olumiant 2mg arm and 32% of the Olumiant 4mg arm achieved a SALT score of 20 or less, which was significantly higher than the 2.6% in the placebo arm. According to a Sungkyunkwan University report, around 25% of adults in Korea are known to have severe or worse alopecia areata, with less than 10% of these patients progressing to the extent that their hair almost falls out.
