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

The Estée Lauder Companies Announces Partnership with Profound to Expand AI Visibility Across Its Global Brand Portfolio14.9.2026 19:32:00 EEST | Press release

The Estée Lauder Companies Inc. (NYSE: EL) today announced a global strategic partnership with Profound, the category-defining AI marketing platform, advancing its ambition to be prestige beauty’s leader in AI-native discovery. The partnership will provide the company with visibility into how its full portfolio of brands is represented across leading generative AI platforms, as well as opportunities to optimize that representation. This partnership establishes the company as the first in prestige beauty to deploy Profound’s capabilities globally across the company’s full portfolio and operationalize Generative Engine Optimization (GEO) and AI marketing at scale. As consumers increasingly turn to ChatGPT, Gemini, and other AI assistants to discover products, compare recommendations, and seek personalized beauty advice before a purchase, The Estée Lauder Companies is partnering with Profound to define the next era of beauty discovery. This partnership will equip the company with a unifie

AMAALA Yacht Club Opens, Putting the Red Sea on the Global Yachting Map14.9.2026 19:00:00 EEST | Press release

Red Sea Global (RSG), the regenerative tourism developer, has announced that AMAALA Yacht Club has officially begun operations, marking a major milestone in establishing the Saudi Red Sea as a new global destination for luxury yachting, sailing and marine tourism. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914160771/en/ AMAALA Yacht Club, the new luxury yachting destination on Saudi Arabia’s Red Sea coast. Nestled within AMAALA Marina Village, the AMAALA Yacht Club is now welcoming founding members and visiting yachts to moor and explore the destination. Located approximately 2,000 nautical miles from Monaco, the club provides a new winter destination for the world’s luxury sailing community, which traditionally migrates from the Mediterranean to the Caribbean or Indian Ocean from October. Positioned closer to the Mediterranean than the Caribbean, AMAALA offers an attractive winter cruising hub and a strategic gateway

Behind the Stage Lights: How Students Learned to Trust Their Voices with Doha Debates14.9.2026 16:40:00 EEST | Press release

During high school years in Model United Nations, Dahlia Al-Ansari learned to argue on behalf of a country she was assigned to represent. But when Doha Debates invited her to join a town hall debate in Toronto this July, she faced an unfamiliar challenge: sharing her own beliefs about a timely issue. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914150232/en/ Students from Qatar, Canada and Mexico during their visit to the University of Toronto as part of the Doha Debates Town Hall experience in Canada. (Photo: AETOSWire) An 18-year-old biological sciences student at Carnegie Mellon University in Qatar, Al-Ansari hadn’t traveled to defend a predetermined position. Instead, she discovered that she was there to think critically, express her own viewpoint and remain open to diverse perspectives. This shift required her to navigate uncharted waters, but “I’m happy that it did,” she says. “It’s showing me the importance of sp

Matt Shafer Joins Golub Capital as Head of Golub Equity Continuation Partners14.9.2026 16:30:00 EEST | Press release

Golub Capital (“the Firm”) today announced the appointment of Matt Shafer as Managing Director and Head of the Firm’s GP-led private equity secondaries strategy, Golub Equity Continuation Partners (“GECP”). In this role, he will be responsible for leading the continued growth and development of the strategy and helping expand the Firm’s equity investment capabilities. Matt will work closely with Greg Cashman, Vice Chair and Co-Head of Golub Capital’s Sponsor Finance practice, to expand Golub Capital’s activity in this growing market. Shafer brings nearly three decades of global experience as an investor, financier and advisor working with private equity firms. He was most recently Head of Capital Solutions and U.S. Private Equity at Northleaf Capital Partners. In this role, Shafer helped lead the firm’s private equity investment activities, including secondaries, co‑investments and structured capital. Prior to Northleaf, he was Partner and Head of Americas Private Equity at Vision Capi

HealthCap Invests in AMRA Medical to Accelerate Global Growth in Quantitative MRI14.9.2026 16:19:00 EEST | Press release

AMRA Medical today announced an investment from HealthCap, one of Europe’s leading life science venture capital firms. This milestone marks a significant step in AMRA’s growth, underscoring market confidence in the company’s vision to transform the measurement and understanding of muscle and fat. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914838191/en/ HealthCap Invests in AMRA Medical to Accelerate Global Growth in Quantitative MRI HealthCap’s backing comes as quantitative MRI gains vital importance in understanding how fat distribution and muscle composition influence disease, treatment response, and patient outcomes. Built on over 15 years of research, AMRA’s proprietary methods move beyond conventional metrics—like weight, and BMI and muscle function tests—to provide the standardized, automated data from advanced muscle and fat imaging necessary for modern clinical research. With its deep scientific expertise and

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