Chugai’s Enspryng (Satralizumab) Approved by European Commission as First At-home Subcutaneous Treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Roche has been granted Marketing Authorization from the European Commission for the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody Enspryng® (satralizumab), created by Chugai, as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD.
“We are very pleased that Enspryng is now approved in the EU as the first subcutaneous treatment for people with AQP4-IgG seropositive NMOSD, with the option to be treated at home,” said Chugai’s President and CEO, Dr. Osamu Okuda. “Enspryng is the first approved therapeutic antibody for which our proprietary recycling antibody technology was applied. We are confident that Enspryng will meaningfully contribute to improving the treatment of people with NMOSD, by fitting into their day-to-day lives.”
The efficacy and safety of Enspryng has been evaluated in large clinical trials representative of the real-world population of people with NMOSD, including those who have only experienced a single NMOSD attack and adolescents. The approval by the European Commission is based on the results from two global phase III clinical studies in people with NMOSD: SAkuraSky Study (NCT02028884) and SAkuraStar Study (NCT02073279). SAkuraSky evaluated Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar assessed monotherapy.
Enspryng is designed to prevent NMOSD relapses by inhibiting IL-6 signal signaling, which is a key driver in NMOSD. Enspryng is currently approved in 54 countries including Japan, the United States and EU countries.
The impact on the consolidated financials for the fiscal year ending December 2021 of Chugai is expected to be negligible.
*Self-administration is not covered in Japan at this time
**Subcutaneous administration at 2-week intervals up to the fourth week of treatment and at 4-week intervals thereafter
New Data of Chugai’s Enspryng (Satralizumab) on Risk and Severity of Relapse in Neuromyelitis Optica Spectrum Disorder (NMOSD) (September 10, 2020)
Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online (November 29, 2019)
Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology (April 24, 2020)
About neuromyelitis optica spectrum disorder (NMOSD)1
NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and causes a continual and significant decrease in quality of life due to permanent neurological disability. Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, pain leading to decreased quality of life. In some cases, attacks of NMOSD result in death. Aquaporin-4 antibodies (AQP4-IgG), pathogenic antibodies, are detected in around 70-80% of NMOSD people. AQP4-IgG is known to target and damage a specific central nervous cell type called astrocytes, resulting in inflammatory demyelinating lesions of the optic nerve(s), spinal cord and brain 2-5. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis 6-10.
Trademarks used or mentioned in this release are protected by law.
1. Neuromyelitis optica spectrum disorder (NMOSD) Online. https://nmosd-online.jp/ Accessed June 2021. (Japanese only)
2. Jarius S, Ruprecht K, Wildemann B et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: A multicentre study of 175 patients. J Neuroinflammation 2012;9:14.
3. Lennon VA, Wingerchuk DM, Kryzer TJ et al. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet 2004;364:2106-12.
4. Marignier R, Bernard-Valnet R, Giraudon P et al. Aquaporin-4 antibody-negative neuromyelitis optica: Distinct assay sensitivity-dependent entity. Neurology 2013;80:2194-200.
5. Takahashi T, Fujihara K, Nakashima I et al. Anti-aquaporin-4 antibody is involved in the pathogenesis of NMO: a study on antibody titre. Brain 2007;130:1235-43.
6. Chihara N, Aranami T, Sato W et al. Interleukin 6 signaling promotes anti-aquaporin 4 autoantibody production from plasmablasts in neuromyelitis optica. Proc Natl Acad Sci USA 2011;108:3701-6.
7. Kimura A, Kishimoto T. IL-6: regulator of Treg/Th17 balance. Eur J Immunol 2010;40:1830-5.
8. Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review. Int J Neurosci2016;126:1051-60.
9. Takeshita Y, Obermeier B, Cotleur AC, et al. Effects of neuromyelitis optica-IgG at the blood-brain barrier in vitro. Neurol Neuroimmunol Neuroinflamm. 2016;4(1):e311.
10. Obermeier B, Daneman R, Ransohoff RM. Development, maintenance and disruption of the blood-brain barrier. Nat Med 2013;19:1584-96.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
For US media
Chugai Pharma USA Inc.
For European media
Chugai Pharma U.K. Ltd.
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Adagio Therapeutics Partners with Biocon Biologics to Bring Potent and Broadly Neutralizing COVID-19 Antibody Treatment to Patients in India and Select Emerging Markets26.7.2021 22:05:00 CEST | Press release
Adagio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced a partnership agreement with Biocon Biologics Ltd., to combat the ongoing COVID-19 crisis in southern Asia. Biocon Biologics Ltd. is a fully integrated biosimilars company and a subsidiary of Biocon Ltd., a global biopharmaceuticals company, (BSE code: 532523, NSE: BIOCON). Under the terms of the agreement, Adagio will provide Biocon with materials and know-how to manufacture and commercialize an antibody treatment based on ADG20 in India and additional select emerging markets. ADG20, Adagio’s lead product candidate, is designed to be a potent, long-acting and broadly neutralizing antibody for both the treatment and prevention of COVID-19 as either a single or combination agent. Unlike other antibody-based therapies specifically targeting SARS-CoV-2, ADG20 has demons
SpeeDx Launch Solution for SARS-CoV-2 Variant Analysis26.7.2021 18:40:00 CEST | Press release
SpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, have launched a new product line of research reagents to support reflex variant analysis for circulating SARS-CoV-2 variants of concern (VOC). The rapid development of PlexPrime® SARS-CoV-2 Genotyping* tests will support investigations and monitoring of the range of emerging and circulating SARS-CoV-2 VOC that have been linked to increased transmissibility, reduced vaccine efficacy, or other characteristics that may require specific public health actions.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005313/en/ SpeeDx unique technology excels in mutation detection applications and can readily be applied to variants reported in the SARS-CoV-2 sequence databases. Compatible with standard qPCR instrumentation, the PlexPrime® SARS-CoV-2 Genotyping research reagents can reduce the manual process of preparing positive samples for sequence analysis
V-Square Appoints Erik Norland as Head of Distribution26.7.2021 17:00:00 CEST | Press release
V-Square Quantitative Management (V-Square) has announced the hiring of Erik Norland as its Head of Distribution. A 20-year industry veteran with asset management, custody, and global markets expertise, Erik’s addition to the team bolsters our strong client-centric approach to deliver customized ESG solutions as we continue to build our reputation as a specialized global asset manager. He will lead the firm's sales, consultant relationship and client service functions across institutional, insurance and wholesale. Mr. Norland, based in Stockholm, will report to Mamadou-Abou Sarr, co-founder and President and will join the global leadership team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005571/en/ Erik Norland, Head of Distribution (Photo: Business Wire) "Erik is a results-focused leader who brings excellent experience in distribution strategy and execution, sales management and client relationship roles. I had th
Private and Public Sector Join Forces Under the Umbrella of the kENUP Foundation: BioNTech Announces Project to Develop the First mRNA-Based Prophylactic Malaria vaccine, and the set-up of Manufacturing Infrastructures in Africa26.7.2021 16:10:00 CEST | Press release
Today, BioNTech SE (“BioNTech”) announced the start of its Malaria project which aims at the development of a safe and highly effective malaria vaccine and the implementation of sustainable vaccine supply solutions on the African continent. The company’s project is part of a programme by the kENUP Foundation to accelerating the eradication of Malaria. This goal was out of reach so far, despite enormous financial and public health efforts of the global community. The scientific and entrepreneurial progress made during the COVID-19 pandemic raise hopes that a highly efficacious vaccine could soon help to eradicate Malaria. BioNTech aims to develop a safe and highly effective mRNA vaccine with durable protective immunity for prevention of malaria and disease associated mortality. To this end, BioNTech will assess multiple vaccine candidates featuring known Malaria targets such as the circumsporozoite protein (CSP), as well as new antigens discovered in the pre-clinical research phase. The
PPG to Expand Production Capacity for PPG ISENSE Gloss Beverage Can Coatings at Delaware, Ohio, Plant26.7.2021 15:02:00 CEST | Press release
PPG (NYSE:PPG) today announced that it is currently adding capacity for the production of overvarnish coatings for beverage can exteriors, including PPG ISENSE™ Gloss coatings, at its Delaware, Ohio, plant. PPG expects the addition of the Delaware plant’s new volume to existing overvarnish capacity at its Oak Creek, Wisconsin, packaging coatings facility will increase the company’s overall production of overvarnish coatings in the U.S. by 40%. “Beverage can manufacturers around the world are facing unprecedented demand for their products,” said Todd White, PPG general manager, U.S. and Canada, and global strategic accounts, packaging coatings. “With this added capacity, we are committed to helping them meet that demand while adding more security to their supply chain for beverage can coatings.” In addition to increasing supply chain security for its customers and the packaging industry, the Delaware plant will provide in-line analytical capabilities for enhanced batch consistency. “PPG
NET ZERO Leaders Summit (Japan Business Conference 2021) - Online Event From Wednesday, July 28 : Latest Information26.7.2021 15:00:00 CEST | Press release
Japan’s Ministry of Economy, Trade and Industry (METI) and the Japan External Trade Organization (JETRO) are pleased to announce the jointly organized “NET ZERO Leaders Summit (Japan Business Conference 2021)” to accelerate innovation in green investment and the realization of carbon neutrality. The event will take place from Wednesday, July 28, and will be held online. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005389/en/ Entrance_Lobby_Image (Graphic: Business Wire) Main Program In the main program, panel discussions will be held between 15 leaders of global companies and organizations. In addition, Mr. SASAKI Nobuhiko, Chairman and CEO of the Japan External Trade Organization (JETRO), will present the opening remarks, Mr. TOKURA Masakazu, Chairman of KEIDANREN (Japan Business Federation), will present the keynote speech and Prime Minister SUGA Yoshihide and Minister of Economy, Trade and Industry KAJIYAMA Hirosh
ADM Accelerates Growth of Leading Global Alternative Protein Platform with Planned Acquisition of Sojaprotein26.7.2021 14:05:00 CEST | Press release
Global nutrition leader ADM (NYSE: ADM) announced today that it has reached an agreement to acquire Sojaprotein, a leading European provider of non-GMO soy ingredients. Established in 1977, Serbia-based Sojaprotein has sales into 65 countries, offering a wide array of non-GMO vegetable protein ingredients for an extensive list of European and global customers in the meat alternative, confectionary, protein bar, pharmaceutical, pet food, and animal feed segments. The company had more than $100 million in sales in 2020. “Thirty years ago, ADM invented the soy vegetable burger, giving rise to the plant-based protein segment. Today, alternative proteins represents one of our core growth platforms, and as this $10 billion global industry grows to $30 billion over the next decade, we are investing to expand our unparalleled capabilities,” said Leticia Gonçalves, ADM’s president of Global Foods. “The addition of Sojaprotein – the largest producer of plant-based protein in southern Europe – ad