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- 2026-03-18 10:27:55
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- Dong-A ST’s Nesp biosimilar export exceeds ₩10 bil.
- by An, Kyung-Jin May 03, 2021 05:53am
- Pic of the Darbepoetin-α product being sold in Japan The cumulative export sales of Dong-A ST’s biosimilar anemia treatment have exceeded 10 billion won. After entering the Japanese market through a partner company at the end of 2019, the sales of Dong-A ST's biosimilar have shown steady growth based on the increasing product recognition and favorable policies set on biosimilars by the Japanese government. According to Dong-A ST on the 1st, its overseas sales of ‘Darbepoetin-alfa’ during the first quarter of this year was 2.9 billion won, a 326.6% increase from the same period of the previous year. ‘Darbepoetin-alfa’ is a biosimilar of the second generation anemia treatment ‘Nesp (darbepoetin-α)’ that was co-developed by Amgen and Kyowa Kirin. Its mechanism of action allows erythropoietin (EPO) to stimulate erythroblasts and accelerate red blood cell production and is used to treat patients with anemia from chronic renal failure or from chemotherapy. The overseas sales of ‘Darbepoetin-alfa’ are solely accrued from its Japan exports. After conducting the Phase I clinical trial on’ Darbepoetin-α,’ Dong-A ST signed a licensing-out agreement on the development and sale of its drug to Sanwa Kagaku Kenkyusho (SKK). Based on a Phase III trial conducted in Japan that compared the efficacy and safety of ‘Darbepoetin-α’ to the original ‘Nesp,’ SKK received marketing approval from Japan's Ministry of Health, Labor and Welfare in September 2019 and released the drug from November of the same year. Dong-A ST exports the finished products that were produced by DM Bio, a biosimilar company under Dong-A Socio Group, to SKK, after which SKK is solely responsible for its local sales. After recording 0.1 billion won in sales in the first year of its release, ‘Darbepoetin-alfa' started making real profit from last year. After exceeding 2 billion won in sales in the second quarter of last year, it has been selling around 3 billion won’s worth every quarter. The cumulative export sales of ‘Darbepoetin-alfa’ since its launch in 2019 to the first quarter of this year amounts to 11.8 billion won. Chong Kun Dang has also launched a Nesp biosimilar in the same market. The company had received marketing approval for its Nesp biosimilar ‘Nesbell’ at a similar period with Dong-A ST and released its product in December of the same year. The Japanese subsidiary of U.S. global pharmaceutical company, Mylan N.V., is in charge of its sales in Japan, however, Chong Kun Dang has not disclosed the individual sales performance of ‘Nesbell’ in Japan. An official from Dong-A ST said, “It has been three years since we released our ‘Darbepoetin-alfa' in Japan, and brand recognition of our product has been increasing. The advantage that our product is cheaper than the original drug, and the subsidies provided by the Japanese government to hospitals that use biosimilars, have also added to our continued positive increase in sales.”
- Company
- Yungjin won patent dispute on Abilify after 6 years
- by Kim, Jin-Gu May 03, 2021 05:53am
- Yungjin won the patent dispute between Otsuka and Yungjin over Abilify (Aripiprazole), a treatment for schizophrenia and bipolar disorder, in six years. This added Abilify's indication for bipolar disorder. Yungjin, which won the dispute, relieved the burden of compensation for damages caused by patent infringement. ◆Generic release as an indication for schizophrenia after product patent expiration On the 29th, the Supreme Court reaffirmed the court's decision in the Abilify patent invalidation lawsuit between Otsuka and Yungjin and dismissed the appeal. It has been six years since the conflict began. In 2014, when Abilify's product patents expired, domestic companies entered the generic market one after another. There are five indications of Abilify: schizophrenia, bipolar disorder, major depressive disorder, autism disorder, and Tourette syndrome. Among them, only the indication for schizophrenia was applied due to the expiration of the product patent. Indications for bipolar disorder and major depressive disorder have been expanded as Otsuka's use patent (expired in 2022) was listed. Considering that Abilify is used for both schizophrenia and bipolar disorder, it was beneficial to launch it in both indications. In March 2015, Yungjin filed a trial claiming that the use patent for bipolar disorder was invalidated. However, the Intellectual Property Trial and Appeal Board took the side of the original company Otsuka in October 2016. Otsuka pushed generic companies in all directions by requesting a trial to verify the scope of their rights and sending out certification of contents. Eventually, generic companies sold only as schizophrenia, excluding bipolar disorder, as an indication. ◆Yungjin, including indications for bipolar disorder However, Yungjin was an exception. Yungjin continued fighting against the defeat of the first trial. It filed a lawsuit with the Patent Court of Korea to cancel the trial decision. The Patent Court of Korea overturned the first trial decision. In July 2017, on the side of Yungjin, he ruled that the patent for use with bipolar disorder was invalid. Otsuka objected. Through an appeal, the case was taken to the Supreme Court. A fierce legal dispute ensued in the Supreme Court. The conclusion came out after 3 years. As with the second trial, a ruling was handed over to Yungjin's side. The ruling included Abilify's indications for bipolar disorder, allowing Yungjin as well as other generics to add indications for bipolar disorder to schizophrenia. It can be added immediately after the trial for reversal of revocation in the Patent Court is concluded with a final judgment. Yungjin escaped the crisis of large-scale counterindemnity. If the Supreme Court ruled in favor of Otsuka, it was because Yungjin had to hand over a significant portion of the sales revenue of generics over the past five years to Otsuka. An official from Yungjin said, "Yungjin had a dispute alone. It was defeated in the first trial, but under the judgment that the logic of invalidity was certain, the second trial was enforced and finally won." He predicted that "Otsuka is also in the process of action against infringement of patent, apart from this lawsuit. It is currently in the process of winning the first trial and in the patent court. In line with this Supreme Court decision, the action against infringement of patent will also be finalized." Patent Attorney Park Jong-hyuk, who represented Yungjin, said, "Unlike composition patents and formulation patents, it is not easy to obtain an invalidation judgment. The Supreme Court recently sided with the patentee, but it means that a ruling to invalidate the use patent was made.” He explained "Bipolar disorder is a recurrent disease of two opposing conditions, mania and depression. It is the judgment of the Supreme Court that if there are no experimental data that clearly show the therapeutic effect of both diseases, it is invalid as a description." According to UBIST, a pharmaceutical market research institute, the amount of Aripiprazole's outpatient prescription last year was ₩25.3 billion. Among them, the generic prescription amount is ₩1.3 billion. However, considering that the prescription of Aripiprazole is 40% to 50% for schizophrenia, 30% to 40% for bipolar disorder, and 20% to 30% for the rest of major depressive disorders, the addition of indications for bipolar disorder will increase the prescription performance of generic companies. It is expected to work positively.
- Company
- SGLT-2 inhibitor combos drive sales in diabetes market
- by Kim, Jin-Gu Apr 30, 2021 06:10am
- The domestic sales of sodium-glucose transport protein-2 (SGLT-2) inhibitors in the diabetes treatment market have repeatedly marked rapid growth. The outpatient prescription sales of SGLT-2 inhibitors in Q1 this year increased by 14% from the previous year, continuing its double-digit growth. The growth is driven by combination therapies. Prescriptions of the two combo therapies ‘Xigduo’ and ‘Jardiance Duo’ have increased by 2.3 times over the past two years. ◆2.3 times increase in prescription of combo drugs… market share also jumps from 27%→39% According to pharmaceutical market research firm UBIST on the 29th, the SGLT-2 inhibitor class of antidiabetic treatments has recorded a total of 32.1 billion won in outpatient prescription sales in Q1 this year. This is a 14% increase from Q1 of the previous year. The SGLT-2 inhibitor market has been increasing quarter by quarter since AstraZeneca’s ‘Forxiga (dapagliflozin) was first introduced to the market in June 2014. Following AstraZeneca, Astellas Pharma’s ‘Suglat (ipragliflozin),’ Boehringer Ingelheim’s ‘Jardiance (empagliflozin),’ MSD’s ‘Steglatro (ertugliflozin),’ also entered the market. Prescription sales of SGLT-2 inhibitors for the last 2 years have been 20.9 billion won in Q1, 23 billion won in Q2, 24.2 billion won in Q3, and 26.1 billion won in Q4 of 2019, and 28.1 billion won in Q1, 29.2 billion won in Q2, 32 billion won in Q3 and 32.1 billion won in Q4 of 2020. The recent market growth has been driven by combination therapies. The SGLT-2 inhibitor combos, AstraZeneca’s ‘Xigduo’ and Boehringer Ingelheim’s ‘Jardiance,’ are in fierce competition. Both drugs are combination therapies that have added metformin to each company’s SGLT-2 inhibitor. At first, total prescription sales of the two products amounted to a mere 5.6 billion won in Q1 2019, with their combined market share being 27%. However, sales have increased over twofold over the next 2 years to reach 12.7 billion won, and their market share also expanded to reach 39%. By each product, Xigduo sold 7.7 billion won, and Jardiance Duo sold 5 billion won in Q1 of this year. The growth surge is more notable in Jardiance Duo, with a 58% increase from Q1 of the previous year. Xigduo also saw a 19% growth during the same period. ◆Forxiga·Jardiance both record ₩9.1 billion… market expected to increase with indication expansion Among monotherapies, Forxiga and Jardiance have recorded 9.1 billion won each. This is an 8% increase for Jardiance and a 4% increase for Forxiga compared to the previous year. Despite the market’s rapid growth, Suglat and Steglatro, however, has shown reduced performance. The prescriptions sales of Suglat and Steglatro recorded only 0.8 billion won and 0.5 billion won in Q1 this year. This was a 4% and 19% respective decrease compared to the Q1 of last year. Industry officials expect the growth of Forxiga and Jardiance to continue for a while. The biggest reason being their expanded indication. In December last year, Forxiiga succeeded in adding a chronic heart failure indication in Korea. As a result, the drug may be used for heart failure, with or without diabetes. Jardiance also has submitted an application for the same indication and is awaiting approval. One variable that might hinder this growth is the release of follow-on drugs by domestic pharmaceutical companies. Currently, Dong-A ST is the only company to have successfully avoided Forxiga's substance patent (to expire in April 2023). The second and third trial remains, however, the company has met the requirements to release a follow-on drug. If wishing to do so, Dong-A ST could release a follow-on drug within this year. Also, Daewoong Pharmaceutical has been speeding up the development of its new drug 'Enavogliflozin.' With Phase III clinical trials currently underway, Daewoong aims to roll out its drug in 2023.
- Company
- Otsuka recently signed a co-promotion contract with Boryung
- by Apr 30, 2021 06:09am
- Otsuka Otsuka will co-promote with Boryung to maintain IMD Mucosta SR in the Rebamipide market. The gastrointestinal drug Rebamipide market, worth ₩100 billion, has recently been fiercely competitive. In December of last year, Yuhan (Recomid SR), GC Pharma (Mucotect SR), Daewoong Pharmaceutical (Mucotra SR), and Daewon Pharmaceutical (Bidreba SR) were approved for IMD of Rebamipide. While Rebamipide is taken three times a day, these IMDs are taken twice a day. A competitive drug has been released in the existing market where generics have been the only so far. The launch of IMDs affected Mucosta's sales, which account for about 10% of Otsuka's total sales. Mucosta recorded ₩17.3 billion in outpatient prescriptions based on UBIST last year. It was down 5.5% from the previous year. Last year's prescription for Bamedin by Samjin was ₩4.6 billion. In order to maintain the No. 1 position in market share, Otsuka was also approved for an IMD Mucosta SR in January after 30 years. Four domestic companies, including Yuhan, are the same through joint development, but Otsuka, which was developed independently, shows a slight difference from the products of the four companies. Otsuka recently signed a co-promotion contract with Yuhan. The original Mucosta could be replaced with a company's product rather than IMD by other companies. The two companies' co-promotion contracts were announced later. In particular, Boryung is expected to play an active part in the highly competitive clinics. Boryung is also in charge of selling Otsuka's antithrombotic drug Pletaal. Domestic pharmaceutical companies were not interested in Rebamipide. This is because the growth trend was insignificant even after 30 years of launch. However, the situation has changed starting with the Ranitidine Incident in September 2019. After Ranitidine was expelled, it affected the growth of Rebamipide. The Rebamipide market, which was only growing at an annual average of around 4%, increased 14.8% year-on-year to ₩110.6 billion in 2020. Existing Rebamipide trend by item
- Company
- Will SK hand over Xarelto generic exclusivity rights to GC?
- by Kim, Jin-Gu Apr 29, 2021 06:09am
- Pic. of Xarelto SK Chemicals may decide to hand over the hard-won generic exclusivity for its generic version of ‘Xarelto (rivaroxaban) 2.5mg’ to GC Pharma. If GC Pharma takes over SK Chemicals’ generic exclusivity, the company will be able to enjoy market exclusivity for the low-dose Xarelto generic with Hanmi Pharmaceutical from this October to July next year. According to industry sources on the 28th, SK Chemicals and GC Pharma have been actively reviewing the possibility of making a deal for SK Chemicals’ generic version of Xarelto 2.5mg. Currently, SK Chemicals and Hanmi Pharmaceuticals own generic market exclusivity for Xarelto 2.5mg. The products that receive the benefit are Hanmi Pharmaceuticals’ ‘Riroxban Tab. 2.5mg’ and SK Chemicals’ ‘SK rivaroxaban Tab. 2.5mg.’ The exclusivity will apply from the date Xarelto’s substance patent expires, October 4th, to July 3rd next year. After successfully avoiding the formulation patent infringement for Xarelto 2.5mg in November 2015, the two companies obtained generic exclusivity by being the first to file for generic approval in July of the following year. The companies finally won the long patent dispute that went up to the Supreme Court in December 2020 and was allowed to exercise their right to generic exclusivity without the burden of a reversal ruling. However, the generic exclusivity owned by the two companies only applies to the 2.5mg dose, as Bayer had not registered a formulation patent for other doses of its Xarelto (10mg·15mg·20mg). In other words, from October, when Xarelto’s substance patent expires, all companies will be allowed to release 10mg·15mg·20mg generics of Xarelto. Still, experts interpret GC Pharm’s deal with SK Chemicals as an attempt to preoccupy the market and gain an advantage. For the other doses, 56 companies have obtained approval for 146 products and are awaiting their release in October. In this context, releasing the product 9 months earlier than the other competitors may provide an advantage in securing brand recognition, distribution, and positioning. Experts explain that the deal also meets the needs of SK Chemicals well. SK Chemicals has not applied for the approval of doses other than the 2.5mg, which suggests that SK Chemicals may not intend to enter the supersaturated market. Officials from GC Pharm and SK Chemicals have said that they cannot confirm or deny issues that are currently being discussed. According to the pharmaceutical market data research firm UBIST, the outpatient prescription sales of Xarelto recorded 50 billion won last year. This was a 1% decrease from the 50.8 billion won in 2019. In the first quarter of this year, Xarelto sold 11.9 billion won. In the new oral anticoagulant (NOAC) market, Xarelto stands in second place after Lixiana, and is followed by Eliquis and Pradaxa.
- Company
- Epidiolex can be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Apr 28, 2021 06:05am
- Epidiolex can be prescribed at general hospitals in Korea According to related industries, Epidiolex (Cannabidiol, CBD Oil), a hemp-based drug for the treatment of patients with rare and intractable diseases among children with epilepsy, has passed the drug commitee (DC) of Seoul National University Hospital. Epidiolex has been reimbursed this month. Since this drug was recognized as an urgently introduced drug by the MFDS in March 2019, it has been struggling to register benefits. With the application of this benefit, the drug cost to be taken by patients has been significantly reduced from about ₩6.7 million per three months to ₩440,000. However, for patients with epilepsy covered by insurance, it is expected that there will be discussions for improvement in the future, used to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 2 years of age and older. The KOEDC played a big role in applying Epidiolex's benefit. The center lowered its domestic supply price to ₩1.1 million through drug price negotiations with the original developer GW Pharmaceuticals, and the registration process was undertaken based on this price, and it was finally listed on April 1. However, even after registration, there are issues to resolve such as supply and demand problems, indications and expansion of benefit standards according to the increased demand. The key is whether Epidiolex can be used stably in the domestic medical field. The third completed phase 3 trial was a comparison of 20 mg/kg per day with placebo in patients with Lennox–Gastaut syndrome. The primary efficacy outcome of median reduction in drop seizures was significantly in favor of Epidiolex with 43.9% versus 21.8% for placebo (P = 0.0135). In patients with Dravet syndrome, a significant decrease in the median convulsive seizure (tonic, clonic, tonic-clonic, or atonic) frequency was seen in patients treated with Epidiolex when compared with placebo within the first month of the maintenance period (P = 0.002 ). The primary outcome endpoint was significant and showed a median reduction of 38.9% for CBD versus 13.3% for placebo (P = 0.01) .Also, side effects such as sleepiness, dizziness, and headache may occur when taking Epidiolex, but it is non-hedonic with no known abuse potential.
- Company
- Viatris Korea-Jeil Pharm to co-promote Lipitor Plus from May
- by Eo, Yun-Ho Apr 28, 2021 06:05am
- Lipitor Plus (ezetimibe/atorvastatin calcium trihydrate) On the 27th, Viatris Korea and Jeil Pharmaceutical announced that they will launch and co-promote the dyslipidemia treatment ‘Lipitor Plus (atorvastatin and ezetimibe)' from May 1st. Jeil Pharmaceutical had received approval for Lipitor Plus from the Ministry of Food and Safety on February 18th, in 3 dosages - 10/10mg, 10/20mg, 10/40mg – for the treatment of primary hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). Lipitor Plus uses atorvastatin, the same active pharmaceutical ingredient (API) used in ‘Lipitor (atorvastatin).’ Jeil Pharmaceutical will manufacture the drug using the original API provided by Viatris Korea. By adding Lipitor Plus to the company’s portfolio in addition to the existing Lipitor, which verified its LDL-C lowering effect and safety profile in large-scale global and domestic clinical trials, the companies expect to be able to provide more personalized treatment options for patients with dyslipidemia in Korea. Viatris Korea and Jeil Pharmaceutical will jointly carry out domestic sales and marketing promotions for Lipitor Plus. Building on the solid partnership established between the two companies through the joint promotion agreement on Lipitor for the treatment of dyslipidemia, the companies plan to inform the clinical field of the clinical value and latest findings of Lipitor Plus. “Based on the partnership between the two companies, we will continue to listen closely to the needs of our patients and HCPs in the changing environment to provide better accessibility,” said He young Lee, Country Manager of Viatris Korea. Viatris Korea is the Korean subsidiary of the Viatris Group that was launched in November 2020 through a merger between Global Pfizer’s business division Upjohn and the global healthcare company Mylan. The company changed its name to Viatris Korea in February.
- Company
- Celltrion acquires Nesina and Actos from Takeda
- by Kim, Jin-Gu Apr 28, 2021 06:05am
- (Clockwise from top left) Actos, Nesina, Edarbi, Whituben & Madipine According to the pharmaceutical industry on the 26th, some of the 18 items that Celltrion acquired from Takeda last year are still being sold under the name of Takeda. This is because the license right in Korea has not yet been completely transferred to Celltrion. Celltrion acquired the rights of 18 items for chronic disease treatment and OTC drugs from Takeda in December of last year in the Asia-Pacific region for $278.3 million (approximately ₩307.4 billion). Celltrion Pharmaceuticals in Korea and Celltrion Healthcare in the rest of the world exercise their rights. The main products are Nesina, a diabetes treatment drug based on DPP-4 inhibitor ,Actos, a diabetes treatment product based on TZD, Edarbi, a treatment drug for hypertension based on ARB, Whituben, and Albothyl, a treatment for stomatitis. Whituben and Albothyl are OTC drugs. About half of them are confirmed to have completed the transfer and transfer of domestic permits. Depending on the item and doses, the progress of the transfer and transfer operation differs. Actos and ActosRyl have been transferred to Celltrion. Actos met is still licensed by Takeda. The license for Nesina Met is still held by Takeda. Celltrion and Takeda are licensed according to the dosage of Nesina and Nesina Act. Nesina 6.25mg is licensed by Celltrion, and Nesina 12.5mg and 25mg are licensed by Takeda. Edarbi, Edarbyclor, and Whituben have licenses from Celltrion, while Albothyl still has licenses from Takeda. Celltrion maintains the domestic joint sales contract as it was before. Nesina is sold by Jeil and Edarbi is sold by Dong-A ST. Ildong is selling only ActosRyl among the Actos series. Whituben and Albothyl are sold and distributed in Korea by GC Pharma. Celltrion plans to complete the transfer of licenses within this year. An official of Celltrion said, "Because the licenses are different for each product, they are being transferred sequentially. We expect all product licenses to be transferred from Takeda to Celltrion within this year." Celltrion's total sales of 18 items acquired from Takeda are estimated at ₩80 billion per year. As soon as the domestic license transfer is completed, the sales of the item will be reflected in Celltrion 's performance. At the end of this year, sales of ₩80 billion will be fully reflected in Celltrion's sales performance.
- Company
- Generics for Eliquis have Rx amount of ₩12.7 billion
- by Kim, Jin-Gu Apr 28, 2021 06:05am
- It was found that Eliquis (Apixaban)'s cumulative prescription amount for generics, which faced a crisis of compensation for damages due to the Supreme Court decision made earlier this month, reached ₩12.7 billion. With the sale of generics stopped at once after the Supreme Court ruling, generic companies have to pay a significant portion of ₩12.7 billion. Eliquis' Rx performance is expected to rebound from next month. However, the NOAC (new oral anticoagulant) market is stagnating, and it is unclear how long it will recover. ◆Eliquis' generics withdrew from the market after recording ₩12.7 billion Eliquis' generics withdrew from the market after recording ₩12.7 billion. According to UBIST, a drug market research institute on the 26th, the cumulative prescription amount of Eliquis generics until the first quarter of this year is ₩12.7 billion. By item, Chong Kun Dang’s Liquisia, ₩4.1 billion, Samjin's Elxaban ₩2.4 billion, Yuhan's Yuhan Apixaban, ₩1.7 billion, Hanmi’s Apixban, ₩1.1 billion, and Yooyoung's Yupix ,₩900 million. Generics for Eliquis have rapidly increased their Rx performance since they were released through patent overcoming in the third quarter of 2019. It surged to ₩400 million in the third quarter of 2019, ₩800 million in the fourth quarter, ₩1.4 billion in the first quarter of 2020, ₩1.8 billion in the second quarter, ₩2.4 billion in the third quarter, ₩2.7 billion in the fourth quarter, and ₩3.2 billionin the first quarter of this year. However, the Supreme Court decision made earlier this month put the brakes on. On the 9th, the Supreme Court overturned the first and second trial rulings in the dispute between BMS and generic companies over Eliquis' product patent on the 9th and sided with BMS. BMS officially announced a claim for damages right after the ruling. Generic companies stopped selling them. It may be a turnaround in the revocation and reconciliation trial. Quarterly Rx performance of Eliquis & Generics (unit: ₩100 million, data:UBIST) The actual compensation amount is expected to be less than the cumulative prescription amount of each company. This is because the amount of compensation for patent infringement is usually determined at the operating profit level, not sales. Eliquis' generics, which were withdrawn from the market by a Supreme Court ruling, can reenter the market after September 2024, when their product patents expire. Generic companies have finally overcome the formulation patent (2031) excluding the product patent in 2019. ◆Eliquis Rx cost reduced by 13%, Will earnings recover from the second quarter? Following the Supreme Court ruling and the subsequent suspension of generic sales, Eliquis is expected to be rebounded in prescriptions from next quarter. Eliquis' Rx amount for the first quarter was ₩10.7 billion. Compared to the same period last year (₩12.3 billion), it decreased by 13%. Eliquis' Rx amount increased to ₩12.5 billion in the second quarter of 2019 just before the generic launch, but has declined since. In the NOAC market, Daiichi Sankyo's Eliquis, Bayer's Xarelto and Boehringer Ingelheim's Pradaxa are competing. It is the key to whether the existing prescription performance of generics will be entirely occupied by Eliquis or will be distributed to other items. Another variable related to the recovery of Eliquis Rx results is the stagnation of the NOAC market. The total NOAC market size increased to ₩46.9 billion until the third quarter of last year, but since then it has decreased for the second consecutive quarter. The market size in the first quarter of this year was ₩44.8 billion. Prescriptions for all three original items decreased excluding Lixiana. Bayer's Xarelto decreased 3% from ₩12.3 billion in the first quarter of last year to ₩11.9 billion in the first quarter of this year. Boehringer Ingelheim's Pradaxa decreased 16% from ₩3.8 billion to ₩3.2 billion. Lixiana, which is the number one in the market, posted sales of ₩15.8 billion in the first quarter, the same as in the first quarter of last year.
- Company
- Roche Korea’s new NMOSD treatment Enspryng is approved
- by Eo, Yun-Ho Apr 27, 2021 06:05am
- Roche’s neuromyelitis optica spectrum disorder (NMOSD) treatment ‘Enspryng’ was approved in Korea. On the 25th, Roche Korea announced that the Ministry of Food and Drug Safety (MFDS) approved Enspryng (satralizumab) for the treatment of adults with aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), NMOSD is a rare autoimmune disorder of the central nervous system that primarily damages the optic nerve and spinal cord, causing loss of vision and neurological damage. Although its clinical characteristics are similar to multiple sclerosis, over half of the patients with NMOSD experience severe loss of vision and gait disturbance to the extent that the patient becomes wheelchair-bound within 5 to 10 years. In particular, 80-90% of the patients experience frequent relapses. As even a single relapse could cause permanent disability, preventing relapses through maintenance therapy is a key goal in the treatment of NMOSD. Enspryng has an innovative mechanism of action that selectively inhibits interleukin-6 (IL-6) receptor activity, which plays a key role in the inflammation associated with NMOSD. The novel recycling antibody technology applied to Enspryng allows for a longer duration of antibody circulation and a longer IL-6 inhibition effect. Also, the new drug has improved dosing convenience allowing the patient or his/her caregiver to inject Enspryng subcutaneously every four weeks at home as maintenance therapy. The MFDS approval is based on the results of the two Phase III clinical studies ▲ SAkuraSky and ▲SAkuraStar. In the studies, Enspryng demonstrated its clinical efficacy in preventing and reducing the risk of relapse in patients with all states of AQP4-IgG seropositive NMOSD. Among AQP4-IgG seropositive patients, over 9 out of 10 patients who were treated with Enspryng and immunosuppressant combination therapy, and over 7 out of 10 patients treated with monotherapy remained relapse-free for approximately 2 years (96 weeks). SAkuraSky, the pivotal Phase III study that evaluated the efficacy and safety of Enspryng in combination with immunosuppressive therapy enrolled 83 patients with NMOSD aged 12 to 74. Results showed that 89% and 78% of patients on Enspryng combination therapy were relapse-free at weeks 48 and 96, achieving a 62% reduction in the risk of relapse compared to patients on placebo (placebo-immunosuppressant therapy combination). In particular, the study showed that 92% of the AQP4-IgG seropositive patients, the patient group approved for the use of Enspryng, remained relapse-free at weeks 48 and 96, and Enspryng reduced the risk of recurrence by 79% compared to placebo. SAkuraStar, the pivotal Phase III study evaluating the efficacy and safety of Enspryng monotherapy, enrolled 95 patients with NMOSD aged 18 to 74. Results showed that 76% and 72% of patients treated with Enspryng remained relapse-free at weeks 48 and 96, and reduced the risk of relapse by 55% compared to the placebo group. 83% of the patients with AQP4-IgG seropositive NMOSD who were treated with Enspryng remained relapse-free at week 48, and 77% at week 96, reducing the risk of relapse by 74% compared to the placebo group. Enspryng was approved by Health Canada (HC) and Japan’s Ministry of Health, Labour and Welfare (MHLW) in June last year. The drug also received approval from the US Food and Drug Administration in August of the same year.
