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- 2025-12-24 13:48:42
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- GC Pharma sells GSK's new shingles vaccine Shingrix together
- by Kim, Jin-Gu Oct 07, 2022 06:03am
- ShingrixGC Pharma and GSK will jointly sell the shingles vaccine Shingrix. The two companies are expected to sell a new shingles vaccine as early as the end of this year. According to the pharmaceutical industry on the 6th, GC Pharma and GSK recently signed a co-promotion contract for Shingrix and started product training for salespeople before its full-scale release. It is expected that the product will be released at the end of this year. GSK obtained Shingrix permission from the Ministry of Food and Drug Safety in September last year. It was originally planned to be released in February this year, but the schedule was delayed. Shingrix is a vaccine used to prevent herpes zoster in adults over the age of 50 and immunocompromised people over the age of 18. When Shingrix is released, it is expected to be the third shingles vaccine in Korea after MSD Zostavax and SK Bioscience's Sky Zoster. It is evaluated that the effect of preventing shingles confirmed in clinical trials is superior to that of the two existing vaccines. In Shingrix clinical trials (ZOE-50) for adults over the age of 50, the effect of preventing shingles was 97% at 3.2 years after vaccination. In clinical trials (ZOE-70) for those aged 70 or older, it was 90% at 3.7 years after vaccination. In the case of Zostavax, a competitive product, it has a preventive effect of 51% for those over 50 and 41% for those over 70. Sky Zoster demonstrated Zostavax and specific heat in clinical practice. It is analyzed that there is no significant difference from Zostavax in terms of prevention rate. GC Pharma has experience in co-selling MSD's shingles vaccine Zostavax in the past. Since 2013, GC Pharma has co-sold Zostavax for eight years until 2020 through a contract extension once after signing a co-promotion contract with MSD. In the process, Zostavax has grown into a large item with annual sales of 80 billion won. However, SK Bioscience launched its competitive product Sky Zoster at the end of 2017, and sales have decreased significantly since 2020 due to the prolonged Corona crisis. According to IQVIA, a pharmaceutical market research firm, Zostavax sales last year amounted to 27 billion won, down 68% in four years from 83.7 billion won in 2017. This year, sales were only 11.6 billion won until the first half of the year. The pharmaceutical industry expects Shingrix to lead the domestic shingles vaccine market to rebound. In the global market, Shingrix's sales, which had already been dampened by the Corona crisis, began to recover in the second half of last year. In the first half of this year, Shingrix's global sales were £1.429 billion, more than doubling compared to the same period last year. An official from GC Pharma and GSK Korea said, "There is nothing to mention regarding Shingrix's domestic sales."
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- Daewoong Pharmaceutical launches botulinum drug in the UK
- by Chon, Seung-Hyun Oct 06, 2022 06:05am
- The botulinum toxin drug developed by Daewoong Pharmaceutical has been released in earnest in the European market. Daewoong Pharmaceutical announced on the 5th that Nabota, a botulinum toxin drug, was officially released in the UK under the product name Nuceiva. It started selling in the UK last month through Daewoong Pharmaceutical's overseas partner Evolus. The UK is the largest single market in Europe, accounting for about 30% of the European botulinum toxin market worth 650 billion won per year. Evolus, a North American and European beauty indication partner of Daewoong Pharmaceutical, is in charge of Nuceiva's distribution and marketing in the UK. Evolus formed a strategic partnership with Wigmore, a local British distributor with a history of more than 35 years, and established a specialized distribution network. Since the beginning of this month, the latest knowledge and Nuceiva product training have been conducted for local medical personnel. Daewoong Pharmaceutical and Evolus will also enter other European countries with high marketability, such as Germany and Austria, to target the European market in earnest. Park Sung-soo, vice president of Daewoong Pharmaceutical, explained, "With the release of Nuceiva in the UK, we have officially entered the U.S. and Europe, the world's No. 1 and No. 2 botulinum pharmaceutical markets." "We will actively promote Nabota's excellent product power in the global market and contribute to enhancing K-Bio's status," he said.
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- ILSUNG signs 3rd generation CCB HTN tx co-promotion
- by Lee, Seok-Jun Oct 06, 2022 06:05am
- ILSUNG, Intro Bio Pharma, and Pharmavision, have signed a partnership for Azelnidipine copromotion. According to ILSUNG on the 4th, Intro Bio Pharma received the first approval in Korea for Azelnidipine-based medicine in September 2021. Azelnidipine is a third-generation CCB hypertension treatment (Calblock) developed by Daiichi Sankyo Korea in Japan. Compared to Amlodipine, it has excellent blood pressure drop effect and fewer side effects, so it is most commonly used in Japan along with ARB hypertension treatment. It is known to have an excellent blood pressure control effect when used in combination with ARB series. Intro Bio Pharma and Pharmavision selected ILSUNG, which has strength in general hospitals, as a partner for Azelnidipine. Amlodipine has recently passed the Pharmaceutical Affairs Evaluation Committee and is expected to be listed. What is unique about this three-way contract is that Pharmavision, a research, and development venture that was established in 2019 and has completed the transfer of about 20 pharmaceutical technologies to many pharmaceutical companies so far. Based on R&D technology, Azelnidipine cooperation between Intro Bio Pharma, a pharmaceutical R&D venture company Pharmavision, and ILSUNG, which is taking a leap forward through innovation, can be a new B2B model. Kim Byung-jo, head of ILSUNG's development division (executive director, Ph.D. ), said, "Azelnidipine can be a new alternative for hypertension patients who have difficulty controlling blood pressure with Amlodipine or Lercanidipine HCl CCB hypertension treatment." Through three-way cooperation, it will become a necessary and differentiated item for patients.
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- Koselugo is keen to discuss the registration of benefits
- by Eo, Yun-Ho Oct 05, 2022 06:11am
- Attention is focusing on whether Koselugo, a drug-free treatment for neurofibroma, will succeed in registering insurance benefits. According to related industries, AstraZeneca's new neurofibromatosis drug Koselugo is under final coordination at the Drug Benefit Standards Subcommittee. AstraZeneca quickly supplemented the data in May and resumed discussions on registration at the HIRA Drug Benefit Evaluation Committee in March. As it is a rare disease area where there were no treatment options, it remains to be seen whether Koselugo will be able to draw a decision this time. Neurofibroma has relied on symptomatic treatment without proper treatment. Neurofibroma is a rare disease in which tumors occur in nerve tissue, bones, and skin, and about 85% are type 1 in which the NF1 gene of the 17th chromosome long arm is mutated. This disease begins with 1~3cm sized cafe au lait macules appearing in children. It experiences symptoms such as brain tumors at the age of 6 and scoliosis at the age of 6 to 10. In adults, Lisch nodule, which occurs in the iris, is mostly found. It is a method of removing possible areas through surgery or chemotherapy and radiation treatment. However, most of the surgeries recur, and most of them are major surgeries, so both medical staff and patients are burdened. In particular, pediatric patients often have to take painkillers even after several surgeries and suffer from speech and motor disorders. Koselugo is a treatment jointly developed by AstraZeneca and MSD. It blocks MEK activity and inhibits cell line growth. In the SPRINT phase 2 clinical trial on which the permit was based, Koselugo reduced tumor size by more than 20% in 68% of administered patients, achieving the primary evaluation index, ORR. In addition, 82% of patients who showed partial reactions continued to respond for more than 12 months. Half of the patients who did not receive treatment suffered from disease progression after 1.5 years, and only 15% of the patients who used Koselugo developed the disease up to three years ago.
