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

Ras Al Khaimah Signs Landmark Friendship Agreement & 10 MoUs during Historic High-Level Tour of South China28.10.2026 15:48:00 EET | Press release

His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, witnesses the signing of a historic agreement between Ras Al Khaimah and Fujian Province, China, concluding a six-day China visit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028878989/en/ His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, witnessed the signing of a landmark agreement between Ras Al Khaimah and Fujian Province, alongside 10 Memoranda of Understanding between entities from the Emirate and their Chinese counterparts, reflecting a shared commitment to broadening cooperation and translating longstanding relations into meaningful opportunities for the future. (Photo: AETOSWire) Signed in Fuzhou, the agreement establishes a framework for strengthening economic, maritime and cultural ties, including cooperation in green supply chains, port logistics, sustainabl

Media Release: Further Up – Allianz Reaches Highest-Ever Brand Value of $30.7 Billion28.10.2026 15:08:00 EET | Press release

A steady climb to a new high: For the eighth consecutive year, Allianz is the world’s most valuable insurance brand and has reached a record $30.7 billion in brand value, lifting it one place to No. 26 in Interbrand’s Best Global Brands 2026 ranking. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028268225/en/ #1 Global Insurance Brand This 9% increase on 2025 further narrows the gap to the world’s most valuable consumer and tech brands, among them Coca-Cola, Disney and Adobe. The upward trajectory is backed by strong business growth and financial performance as well as a global brand strategy that is built on trust and distinguished with customer relevance and care. Oliver Bäte, Chief Executive Officer of Allianz SE, said: "In a highly competitive brand landscape, we have maintained our momentum by focusing on what matters most to our customers: their health and personal finances. Our strong business fundamentals and con

Seoul Semiconductor Ends Need for Rare Earths in White LEDs28.10.2026 15:03:00 EET | Press release

For three decades, white LEDs have depended on rare earth materials such as yttrium aluminum garnet (YAG) layered onto a blue LED chip (Figure 1). Seoul Viosys Co., Ltd. (KOSDAQ: 092190) today announced that it has broken that dependence. It has developed and begun mass producing a chip that emits white light without rare earths. The chip can be as small as 10 micrometers (µm). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028475699/en/ Figure 1. New invention: white WICOP 3 (source: Seoul Semiconductor Co., Ltd.) Seoul Viosys and its parent company Seoul Semiconductor Co., Ltd. (KOSDAQ: 046890) opened the micro LED market with WICOP. WICOP is a chip architecture that eliminates the package altogether. Doing away with the package is widely regarded in the industry as a revolution in six decades of semiconductor history. With WICOP, the two companies have already developed and mass produced ultraviolet, blue, green, red a

Gurobi’s 2026 State of Mathematical Optimization Report Reveals Growing Convergence of AI and Optimization28.10.2026 15:00:00 EET | Press release

Gurobi Optimization, LLC, the leader in decision intelligence technology, today announced the release of its 2026 State of Mathematical Optimization Report. Based on a survey of 382 non-academic professionals across industries, the report examines how businesses are putting optimization to work, and how its use is evolving alongside other AI technologies. In a notable shift, 79% of respondents now use GenAI or large language models (LLMs) in their optimization work, up from 30% in 2025, with 37% using these tools systematically in their development workflows. Respondents see the greatest potential for this combined approach in code generation and debugging (68%), model formulation (67%), and natural-language interaction with optimization models (62%). Other key findings include: Optimization is becoming part of everyday operations: 52% of respondents say optimization supports ongoing decision-making at their organization, and 45% run it automatically in production workflows. Demand for

1GLOBAL Empowers WEtell to Offer Sustainable Global Travel Connectivity28.10.2026 15:00:00 EET | Press release

1GLOBAL, a pioneer in global telecommunications solutions, today announced a new partnership with climate-neutral mobile phone provider WEtell to bring sustainable, app-based travel connectivity to its customers worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028932032/en/ The partnership integrates 1GLOBAL's eSIM infrastructure into WEtell's digital platform, delivering sustainable global travel connectivity to WEtell customers. WEtell, founded in Freiburg in 2019, focuses on sustainable mobile communication, with an ethos of promoting eco-conscious consumption and integrating environmental and social values into its mobile services. When WEtell users connect to the internet or make calls, their typical CO₂ footprint when doing so is calculated and offset by WEtell to ensure climate-neutrality. Since market launch in 2020, WEtell has offset a total of 1,537 tonnes of CO₂, the equivalent of taking 360 petrol car

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