- LOGIN
- MemberShip
- 2026-04-14 23:24:31
- Policy
- Six more Arcoxia generics acquire generic exclusivity
- by Lee, Tak-Sun Apr 29, 2021 06:09am
- Six generic products of Arcoxia that received belated approval acquired generic exclusivity. Other Arcoxia generics that were previously approved will go on sale next month. On the 27th, the Ministry of Food and Drug Safety approved the generic etoricoxib products of 6 pharmaceutical companies - Theragen Etex, Guju Pham, Union Korea Pharm, Aju Pharm, Hana Pharm, Hutecs Korea Pharmaceutical. The products also obtained generic marketing exclusivity, applicable from the day after (28th) to December 25th. The 6 products will be produced by Theragen Etex under a consignment manufacturing agreement. Generics of Arcoxia from Arlico Pharm, Boryung Pharmaceutical, Reyon Pharmaceutical, and Samil Pharmaceutical was first approved last month. These companies also acquired generic exclusivity for their products until December 25th of this year. During this period, drugs of the same substances are not allowed to be sold in the market. Like the 4 products previously approved, the 6 products approved today also succeeded in avoiding Arcoxia’s patent by filing a defensive confirmation trial for the scope of right for Arcoxia’s crystalline patent. Applications for approval were submitted on December 22nd, at the time of the original PMS expiry. However, due to a delay in the review, the 6 products produced by Theragen Etex received approval a month later than the 4 products produced by Arlico Pharm. Thus, the release of the 6 products is expected to be delayed by a month. The 4 products produced by Arlico Pharm will be sold from the 1st of next month after completing the listing process. Being generic exclusivity products, the listing process for the said products was completed a month faster than general generics. According to UBIST, Arcoxia recorded outpatient prescription sales of 3.3 billion won last year. Arcoxia is a competitor to ‘Celebrex,’ which dominates the nonsteroidal anti-inflammatory analgesic market. As most of the pharmaceutical companies that will be releasing the Arcoxia generics also own their own generic versions of Celebrex, the industry expects the approval to create a synergistic effect of diversifying the prescription options in the analgesic market. Accordingly, further attention is being paid to whether the introduction of these Arcoxia generics may impact the Celebrex-dominant market.
- 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.
- Policy
- AZ vaccine vaccination is being reviewed in the 2nd quarter
- by Kim, Jung-Ju Apr 29, 2021 06:09am
- The quarantine authorities are considering expanding the age range for AstraZeneca COVID-19 vaccine. Although it is currently impossible to select a product, it will be reviewed after sufficiently diversifying the quantity while changing the inoculation institution for each product characteristic in the future. Thr KCDA Commissioner Jeong Eun-kyung responded in this way during the inquiry time for the COVID-19 Central Disease Control Headquarters Regular Briefing' during the day on the 26th. The quarantine authorities are considering expanding the possibility of a second quarter vaccination plan. The authorities currently supply 3.87 million doses of AstraZeneca and Pfizer vaccines, and are expected to supply a total of 18.09 million doses by the second quarter. She said, "Currently, we are considering expanding the age target to under the age of 65 as a plan to review changes to the vaccination plan for the second quarter including AstraZeneca to be additionally introduced through COVAX and AZ vaccination of 65-74 years old, including the amount of vaccination plan for under 30s ." In order to increase the vaccination rate of chronically ill and socially indispensable personnel, including health care workers, she said, "We will provide vaccination guidance through each institution and organization and strengthen the guidance so that vaccination can be administered." She suggested that although it is difficult at present as to the possibility that the public can choose and inoculate a vaccine, it is possible to some extent if the quantity is sufficiently diversified and expanded. She said, "It will be difficult in the third quarter to ensure that people can get the vaccine they want by guaranteeing the right to choose a vaccine." "However, in the third quarter, more vaccines such as Pfizer, Moderna, and Novavax will be available, so we are working on a vaccination plan accordingly." She added, "In this case, the medical institution will be different so that the vaccine can be vaccinated according to the characteristics of the vaccine. Because the vaccination is carried out through a consignment medical institution or a private primary medical institution, and as an alternative method, the vaccination center or a hospital of a certain size can be different, so the most suitable vaccine type, inoculation institution, and characteristics. We will proceed to guide the vaccination by matching the appropriate vaccination targets.”
- Policy
- First retinoid acne treatment in 20 years comes to Korea
- by Lee, Tak-Sun Apr 28, 2021 05:17pm
- Galderma’s Aklief cream (trifaortene), the first new retinoid molecule to receive U.S. FDA approval for the topical treatment of acne in more than 20 years, has finally set foot in Korea. On the 27th, the Ministry of Food and Drug Safety (MFDS) approved Galderma Korea’s ‘Aklief cream 0.005%’ as a new drug. The new drug is indicated for the topical (facial and truncal) treatment of moderate acne vulgaris that is characterized by comedones, papules, and pustules. In particular, Aklief cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. By stimulating RAR, the drug modulates target genes that are associated with various processes, including cell differentiation and mediation of inflammation. Retinoid is a vitamin A compound that is used to treat acne. For the first time in 20 years, the U.S. FDA had approved the new retinoid product, Aklief cream, in September 2019. Alief cream showed an improved effect on acne compared to existing creams in clinical studies. In a clinical trial on patients with moderate facial and truncal acne, 1,214 subjects who were treated with Aklief cream showed over 10% improvement in IGA (Investigator’s Global Assessment) for the face and PGA (Physician’s Global Assessment) for the trunk compared to the 1,206 subjects treated with vehicle cream. Galderma Korea has been leading the topical acne treatment market in Korea with its products, including its Epiduo gel. The Epiduo brand has recorded 2.3 billion won in sales last year according to IQVIA. With the approval of Aklief cream bringing a new treatment option into the acne market, Galderma Korea's influence in the market is expected to increase.
- 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.
- Policy
- The government signed an additional 40 million doses
- by Kim, Jung-Ju Apr 28, 2021 06:05am
- The government has signed an additional 40 million doses of Pfizer's COVID-19 vaccine product. As a result, Korea has secured twice the amount of vaccine vaccination in the country, enabling it to achieve the goal of forming collective immunity in November. Pan-government vaccine introduction TF (Team Leader Kwon Deok-cheol, Minister of Health and Welfare) announced that an additional purchase contract for 40 million Pfizer COVID-19 vaccines (for 20 million people) was signed by holding an emergency briefing during the day on the 24th. The government explained that after forming a pan-government vaccine introduction TF to stably supply COVID-19 vaccine on the 1st, it has mobilized all of its government-wide capabilities, including diplomatic efforts, by consistently meeting with each vaccine pharmaceutical company. This contract is the result of ongoing negotiations by discussing the supply of vaccines through video conferences with Pfizer with Kwon Deok-cheol, head of the Pan-Government Vaccine Introduction Task Force on the 9th and 23rd of this month. ◆Signed an additional purchase contract for Pfizer vaccine= This year, a total of 66 million doses of Pfizer vaccine, which was originally 26 million doses and 40 million doses contracted, were supplied, resulting in a total of 33 million Pfizer vaccines. Pfizer's vaccine has been supplied in 1.75 million doses so far, including 7 million doses by the end of June, and plans to supply 59 million doses sequentially from the third quarter. Pfizer vaccines have been supplied regularly every week since the start of supply on March 24th. With the signing of an additional purchase contract this time, the foundation for a more stable supply of COVID-19 vaccine has been laid. ◆COVID-19 Vaccine Supply Status and Plan The total number of COVID-19 vaccines secured by Korea this year amounted to 192 million doses, a total of 99 million. This is the amount that can be vaccinated for about 1.9 times of the total population in Korea and 2.75 times for the 36 million vaccination targets for the formation of collective immunity. The vaccine contracted for this year was for 79 million people, enough to secure collective immunity, but additional purchases laid the foundation to accelerate the time to achieve collective immunity. It is possible to prepare for additional demands that may arise in the future, such as the 3rd vaccination (called booster shot) to cope with the mutant virus and the expansion of the target age for vaccinations under the age of 18 to prepare for the uncertainty in the international vaccine supply and demand. First of all, the government plans to do its best to achieve the target inoculation for 12 million people with the 18.09 million doses confirmed by the end of June. AstraZeneca and Pfizer vaccines, which are currently being vaccinated, have already supplied 3.87 million doses of vaccine, and a total of 18.09 million doses will be supplied by the second quarter. The government plans to closely monitor the vaccine supply situation on a full-cycle basis to ensure that 18.09 million doses will be supplied without disruption, while additionally introducing some of the Novavax, Moderna and Janssen vaccines within the first half of the year, so that up to 20.8 million doses can be supplied. The government said, "By the end of June, 12 million people are vaccinated to prevent infection in high-risk groups such as nursing hospitals, facility admissions, and residents, thereby preventing severe and death, and through vaccinations for COVID-19 treatment, response personnel, and health care workers. We expected to be able to contribute to the maintenance of the quarantine system." From July, AstraZeneca and Pfizer, as well as Novavax, Moderna, and Janssen vaccines are expected to be supplied in earnest. Accordingly, a total of 100 million vaccines are planned to be supplied by the end of September. The total amount negotiated by the end of September is about 80 million doses of AZ, Pfizer, Novavax, Moderna, and Janssen, and when added to the supply in the first half, about 100 million doses of vaccine will be supplied by the end of September. This is an amount that can be vaccinated to more than 50 million people, and if the supply is smooth, it will be possible to inoculate all 44 million people over the age of 18 with only the amount until the end of September. In order to form collective immunity, vaccination of about 36 million people, or 70% of 52 million people, is necessary. The government said, "Through this additional purchase contract, it is possible to secure a sufficient amount of vaccine and achieve early achievement even after meeting the goal of forming population immunity in November." This is the result of specifying the supply schedule of vaccines, which were scheduled to be supplied in the second half of the year, by pursuing additional contracts through the pan-government vaccine introduction TF and expanding the volume of existing contracted vaccines in the third quarter. Although the supply and demand of vaccines worldwide is uncertain, the government said that through additional purchase contracts and quarterly consultations on supply, the government laid the foundation for more stable and rapid vaccination. About 90 million doses to be supplied in the fourth quarter will be used to respond to a variety of situations in a relaxed manner, and to actively utilize additional vaccinations if necessary. The government said, "In the future, we plan to actively cope with various situations that may arise during the vaccine supply and demand process through comprehensive support such as approval of COVID-19 vaccine, release of national lots, and supply of raw and subsidiary materials. By the end of June, 12 million people will be vaccinated and all government-wide capabilities will be mobilized to achieve collective immunity in November." Minister Kwon Deok-cheol said, "The government will do its best to prevent quarantine, introduce vaccines, and vaccinations so that the people's precious daily lives can be restored. I sincerely ask the people to believe in and actively cooperate with the government's plans and guidance for securing vaccines and vaccinations." The government plans to continue meticulous efforts on vaccine safety. The KCDA Commissioner Jeong Eun-kyeong said, "The vaccines contracted by our government are products that have been approved for safety, and the benefits of vaccination outweigh the risks. I hope you will actively participate in the order of vaccination."
- 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.
