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

Wyss Geneva Steps Into Its Next Chapter11.6.2026 14:33:00 EEST | Press release

The Wyss Center for Bio and Neuroengineering in Geneva is pleased to announce the appointment of Dr. Tracy Laabs as Director, effective July 1st 2026. Dr. Laabs succeeds Prof. Dr. Erwin Böttinger, who leaves behind a fundamentally transformed organization: one that no longer just pursues breakthrough science but systematically turns it into ventures that reach patients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611328520/en/ Dr. Tracy Laabs, incoming Director, Wyss Center Geneva Since joining the Wyss Center as Director in April 2023, Prof. Böttinger brought a bold vision: to evolve the Center from a portfolio of promising projects into a disciplined engine for venture creation. Under his leadership, the Center spun off six companies in two years (including ABILITY Neurotech SA and Clee Medical SA in 2025) while simultaneously building a robust pipeline of next-generation programs in AI-guided neuromodulation and min

BeOne Showcases Landmark Phase 3 Data in CLL Patients Aged 80+ at EHA 2026, Reinforcing BRUKINSA Benefit11.6.2026 14:24:00 EEST | Press release

BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of a large Phase 3 dataset in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) aged 80 and older, showing sustained benefit with BRUKINSA after nearly 6.5 years of follow-up, reinforcing its role as the foundational BTK inhibitor. BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy vs. ibrutinib in a Phase 3 trial.1 These data, one of the largest datasets of older patients with treatment-naive CLL, will be presented at the 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden. Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said: "While the median age of diagnosis for CLL is 70 and the average age of treatment initiation is 75, many pivotal trials still underrepresent the patients that physicians most often see in practice. These data show that the durable benefit of

Clearlake Expands Liquid Credit Platform With Acquisition of LCM Asset Management’s CLO Contracts11.6.2026 14:00:00 EEST | Press release

Clearlake Capital Group, L.P. (“Clearlake” or the “Firm”), a global investment firm managing integrated platforms spanning private equity, liquid and private credit, and other related strategies, today announced that its credit platform, Clearlake Credit, will assume management of CLOs managed by LCM Asset Management, LLC. The transaction adds 31 CLOs representing more than $5 billion of assets under management and increases assets managed by Clearlake Credit to approximately $39 billion across liquid credit, private credit, and other customized credit solutions. The acquisition further broadens the Firm’s capabilities, deepens its relationships with institutional investors, and reinforces its client-centric approach and commitment to seeking attractive risk-adjusted returns across market cycles. Milbank LLP and Dechert LLP represented Clearlake Credit in the transaction. GreensLedge Capital Markets advised the seller. About Clearlake Clearlake Capital is a leading global alternative a

Takeda’s Zasocitinib Significantly Outperforms Deucravacitinib in Head-to-Head Phase 3 Psoriasis Study, Promising to Redefine Oral Treatment Expectations11.6.2026 14:00:00 EEST | Press release

Takeda (TSE:4502/NYSE:TAK) announced positive topline results for the Phase 3, randomized, multicenter, double-blind study comparing zasocitinib (TAK-279), an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, to deucravacitinib in adults with moderate-to-severe plaque psoriasis (PsO). In the LATITUDE Atlas (TAK-279-PsO-3004) head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib for the primary endpoint, Psoriasis Area and Severity Index (PASI) 100 response rate at week 16. The study also demonstrated statistical superiority over deucravacitinib for all key secondary endpoints, including PASI 90 response and Static Physician's Global Assessment (sPGA) 0 at week 16. Zasocitinib was generally well tolerated with a consistent safety and tolerability profile and no new safety signals identified. Perspectives on head-to-head zasocitinib study “In this head-to-head study, zasocitinib clearly demonstrated

L&T Technology Services, Databricks Partner to Deliver Industrial AI at Scale for Asset-Intensive Industries11.6.2026 13:30:00 EEST | Press release

L&T Technology Services (BSE: 540115, NSE: LTTS), a global leader in AI, Digital & ER&D Consulting Services, today announced a strategic go-to-market partnership with Databricks, the leading Data and AI company, to co-develop and deliver Industrial AI solutions that advance Engineering Intelligence (EI) for asset-intensive enterprises. Anchored in LTTS' Sustainability segment, spanning Process Engineering, Discrete Manufacturing and Industrial Products, the partnership will support Energy, Petrochemicals and Industrials clients globally. As industrial organizations seek to unlock greater value from decades of operational and engineering data, the alliance will combine LTTS’ deep domain capabilities with the Databricks platform to transform complex plant data into Engineering Intelligence - enabling improved asset reliability, operational efficiency and sustainability performance. The partnership brings together LTTS’ expertise in forward looking technologies and extensive experience ac

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