Business Wire

Chugai’s Enspryng (Satralizumab) Receives Regulatory Approval from FDA for Neuromyelitis Optica Spectrum Disorder

17.8.2020 09:00:00 EEST | Business Wire | Press release

Share

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the U.S. Food and Drug Administration (FDA) has approved the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody, Enspryng™ (US generic name: satralizumab-mwge) (hereafter, Enspryng) created by Chugai for the treatment of adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). Enspryng is administered subcutaneously every four weeks**. Enspryng was granted Breakthrough Therapy Designation in December 2018 and the US Biologics License Application (BLA) was filed in August 2019 by Genentech Inc., a member of Roche Group.

This approval is based on the results from two global phase III clinical studies in patients with NMOSD: SAkuraSky Study (NCT02028884) and SAkuraStar Study (NCT02073279). SAkuraSky is a study to evaluate Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar is a study to evaluate Enspryng as monotherapy.

Enspryng, created by Chugai, is a pH-dependent binding humanized anti-IL-6 receptor antibody, which was the first product developed by applying our proprietary recycling antibody technology. The drug is believed to prevent relapse of NMOSD by inhibiting IL-6 signal signaling which is a key driver in NMOSD. Enspryng has been approved in Canada, Japan and Switzerland. Enspryng is designated as an orphan drug in Europe. The application was accepted for review by the European Medicines Agency in 2019.

*Self-administration is not included in Japanese package insert
**Subcutaneous administration at 2-week intervals up to the fourth week of treatment and at 4-week intervals thereafter

[Reference]

About neuromyelitis optica spectrum disorder (NMOSD)

NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and cause 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 at least two-thirds 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 1-4. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis 5-9.

Diagnostic criteria introduced in 2006 for NMO were characterized by inflammation of the optic nerve (optic neuritis) and the spinal cord (myelitis). These were revised in 2007 with the definition of NMOSD, proposed for diseases with either optic neuritis or myelitis. In 2015, the definition of NMOSD further revised to include a broader spectrum of diseases. The diagnostic term NMOSD is now widely used 10.

Trademarks used or mentioned in this release are protected by laws.

Sources
1. 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.
2. Lennon VA, Wingerchuk DM, Kryzer TJ et al. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet 2004;364:2106-12.
3. 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.
4. 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.
5. 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.
6. Kimura A, Kishimoto T. IL-6: regulator of Treg/Th17 balance. Eur J Immunol 2010;40:1830-5.
7. Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review. Int J Neurosci2016;126:1051-60.
8. 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.
9. Obermeier B, Daneman R, Ransohoff RM. Development, maintenance and disruption of the blood-brain barrier. Nat Med 2013;19:1584-96.
10. Wingerchuk DM, Banwell B, Bennett JL et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology 2015;85:177-89.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Tomoko Shimizu
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp

For US media
Chugai Pharma USA Inc.
Casey Astringer
Tel: +1-908-516-1350
E-mail: pr@chugai-pharm.com

For European media
Chugai Pharma U.K. Ltd.
Tania Richards
Tel: +44-20-8987-5680
E-mail: pr@chugai.eu

For Taiwanese media
Chugai Pharma Taiwan Ltd.
Susan Chou
Tel: +886-2-2715-2000
E-mail: pr@chugai.com.tw

For Investors
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
Toshiya Sasai
Tel: +81-3-3273-0554
E-mail: ir@chugai-pharm.co.jp

About Business Wire

Business Wire
Business Wire



http://www.businesswire.com

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

INNIO to Supply Technology for a Landmark Project in Texas, Reinforcing Grid Stability12.12.2025 10:59:00 EET | Press release

INNIO Group, a leading energy solution and service provider, is collaborating with the U.S. power utility Greenville Electric Utility System (GEUS) on a landmark 104-megawatt (MW) power plant. The new plant is designed to help reinforce grid stability, cover peak loads, and enable greater integration of renewable energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211712708/en/ Jenbacher J920 FleXtra “This project is a milestone for Texas and for INNIO. With fast-start capability, flexibility, and sustainability, we are creating the energy infrastructure that modern grids need: reliable, growth-promoting, and supporting the expansion of renewables,” said Dr. Olaf Berlien, President and CEO of INNIO Group. Groundbreaking for the plant’s construction took place in early December, with commissioning scheduled for summer 2027. The groundbreaking marks the beginning of the largest installation to date of Jenbacher J920 FleX

Kioxia Develops Core Technology that Will Allow the Practical Implementation of High-density, Low-power 3D DRAM12.12.2025 07:24:00 EET | Press release

Kioxia Corporation, a world leader in memory solutions, today announced the development of highly stackable oxide-semiconductor channel transistors that will enable the practical implementation of high-density, low-power 3D DRAM. This technology was presented at the IEEE International Electron Devices Meeting (IEDM) held in San Francisco, USA, on December 10, and has the potential to reduce power consumption across a wide range of applications, including AI servers and IoT components. In the era of AI, there is growing demand for DRAM with larger capacity and lower power consumption that can process large amounts of data. Traditional DRAM technology is reaching the physical limits of memory cell size scaling, prompting research into the 3D stacking of memory cells to provide additional capacity. The use of single-crystal silicon as the channel material for transistors in stacked memory cells, as is the case with conventional DRAM, drives up manufacturing costs, and the power required t

BEYOND Developments Reveals a New Vision for Purposeful Living on Dubai Islands with SIORA11.12.2025 19:02:00 EET | Press release

BEYOND Developments, the bold and design-led real estate developer shaping next-generation waterfront destinations in the UAE, today unveiled SIORA, its first beachfront masterplan on Dubai Islands and the company’s second large-scale community within a year. The launch underscores BEYOND’s accelerated growth and strong alignment with Dubai’s future urban vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211014389/en/ BEYOND Developments - SIORA Masterplan at sunset - Dubai Islands (Photo: AETOSWire) Spanning over 2M square feet, SIORA is conceived as a coastal sanctuary inspired by Japanese garden philosophies, including the pursuit of Ikigai, the Japanese concept of finding purpose and fulfilment in everyday life. In this context, it reflects a philosophy of creating spaces that bring clarity, balance, and a sense of meaning, where architecture nurtures wellbeing and restores harmony between people, nature, and pla

3Degrees Welcomes David Dines to Board of Directors11.12.2025 18:00:00 EET | Press release

3Degrees, a global leader in renewable energy and climate solutions, is pleased to announce the appointment of David Dines to its Board of Directors, effective December 8, 2025. Dines brings more than four decades of leadership experience across global energy, commodities, financial services, transportation, and industrial markets. He served on the executive team as Chief Financial Officer and Corporate Senior Vice President at Cargill, Inc., the largest privately held company in the United States, where he oversaw enterprise-wide financial strategy, capital deployment, and financial performance. During his 29-year career at Cargill, Dines led multiple global businesses, played key roles in major technology and process transformations, and was a member of Cargill’s Commodity Risk, Financial Risk, and Process, Data, and Technology Committees. “We are thrilled to welcome David to the 3Degrees board,” said Philippe Vedrenne, CEO, 3Degrees. “He has an exceptional command of financial stewa

ITC Infotech wins PTC Partner Network Award for FY25 in the PLM Category11.12.2025 16:40:00 EET | Press release

ITC Infotech, a leading global technology services and solutions provider, has been awarded the PTC Partner Network Award for FY25 in the Product Lifecycle Management (PLM) category. This prestigious recognition, awarded to a single partner globally, celebrates excellence in deploying Enterprise PLM software, enabling global and cross-functional teams to effectively manage product data and providing a trusted system for product information. The award underscores ITC Infotech’s leadership in PLM-led digital transformation, as well as its strategic alignment with PTC’s Intelligent Product Lifecycle vision, which helps customers build a structured product data foundation that serves as the backbone for AI-driven transformation. Through its specialized DxP Services, ITC Infotech has helped enterprises transform and modernize their product development lifecycle processes, seamlessly transition to SaaS ecosystem and build digitally connected, intelligent and future-ready solutions to acceler

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye