Business Wire

Chugai’s Enspryng (Satralizumab) Approved by European Commission as First At-home Subcutaneous Treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD)

28.6.2021 09:11:00 EEST | Business Wire | Press release

Share

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

[Reference]

New Data of Chugai’s Enspryng (Satralizumab) on Risk and Severity of Relapse in Neuromyelitis Optica Spectrum Disorder (NMOSD) (September 10, 2020)
https://www.chugai-pharm.co.jp/english/news/detail/20200910150000_765.html

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.

Sources
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.

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.,
Takayuki Sakurai
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

Elliptic Sets the Engineering Bar for On-Chain Risk With “Built for Compliance” Paper as New Rules Take Hold and Banks Launch a Joint Stablecoin1.10.2026 16:40:00 EEST | Press release

Elliptic, the global leader in on-chain risk management, today published Built for compliance, a paper setting out the nine engineering decisions that determine whether an on-chain risk system can support fast, accurate and defensible compliance decisions at agentic scale. Machines are already moving money on their own, at machine speed. Compliance teams now have to make hundreds of thousands of decisions a day, at that same speed. However, many on-chain risk systems were never engineered to support that pace. A compliance system that computes exposure on a schedule delivers stale results. One that defines blockchain coverage loosely enough lets a screening miss exposure entirely. A system that skips testing disaster recovery, a spike or an outage, takes down the customer’s compliance system too. That gap between machine speed and system design is exactly what regulators are now closing. As US regulators put together market-structure regulation, the GENIUS Act's stablecoin rules take h

Andersen Global Enhances Pakistan Legal Presence with New Member Firm1.10.2026 16:30:00 EEST | Press release

Andersen Global strengthens its legal presence in Pakistan as Samdani & Qureshi, a collaborating firm since 2021, rebrands to Andersen Legal in Pakistan and is the latest member firm to join the organization. Headquartered in Islamabad, Andersen Legal in Pakistan advises domestic and international clients, including businesses, investors, financial institutions, public sector entities, development organizations, and individuals, on legal, commercial, and regulatory matters. The firm also handles arbitration and dispute resolution, advising on complex transactions, investments, finance, projects, and contentious matters in Pakistan and across borders. “Our approach is grounded in senior attention, clear communication, and disciplined analysis, with a focus on delivering advice that clients can put into action,” said Nudrat Ejaz Piracha, partner at Andersen Legal in Pakistan. “Joining Andersen Global enables us to build on this approach by drawing on additional capabilities and perspecti

Impartner Releases AI Ecosystem Playbook to Help Organizations Move from AI Experimentation to Execution1.10.2026 16:00:00 EEST | Press release

Impartner, the world’s leading partner revenue orchestration platform, today announced the release of its AI Ecosystem Playbook, a new resource designed to help leaders and teams assess their current AI capabilities, identify areas where AI can support business goals, and develop a practical path to implementation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261001661549/en/ Impartner’s AI Ecosystem Playbook helps organizations assess AI readiness and identify opportunities to apply AI across PRM 3.0, partner revenue orchestration, and the partner lifecycle. As AI moves from experimentation into everyday operations, companies need more than a collection of potential applications. They need a framework for understanding where they are ready to apply AI, where foundational gaps could limit its impact, and which opportunities should be prioritized. Impartner’s AI Ecosystem Playbook provides guidance through a maturity model,

Whiteford Adds Six Partners in New York City, Expanding its Litigation, International and Corporate Practices1.10.2026 16:00:00 EEST | Press release

Whiteford, Taylor & Preston, a full-service law firm with offices across the East Coast, today announced that six partners from Chambers-rated Lazare Potter Glazer & Moyle LLP have joined Whiteford’s New York office: David E. Potter, James F. Moyle, Johannes K. Gäbel, Jaipat Singh Jain, Anna Pia D. Felix and Jacob Englander. This team expands Whiteford's New York office to more than two dozen attorneys and deepens the firm's commercial and securities litigation, employment, cross-border and corporate capabilities in the New York market. The six partners bring decades of combined experience representing mid-market companies, investment advisers, hedge funds, foreign corporations, entrepreneurs and executives in litigation, regulatory investigations, and complex business transactions. "We are expanding with our clients, our markets and our reputation," said Martin Fletcher, Whiteford's Managing Partner. "This team validates our approach. Whiteford’s platform is designed to help grow and

Skechers Enters Super Shoe Era With Innovative Skechers AERO Elite1.10.2026 15:20:00 EEST | Press release

Skechers is redefining what it means to run fast with the Skechers AERO Elite. The latest addition to the innovative Skechers AERO Series makes its global racing debut today—marking a landmark moment as the performance brand’s first super shoe. Engineered to perform from 5Ks to marathons, the design minimizes weight and maximizes responsiveness, all while delivering Skechers’ signature comfort. The AERO Elite is built to win with the performance runners at any level need to go further, faster, and achieve that next personal record. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261001865320/en/ Introducing the Skechers AERO Elite, the brand’s first super shoe designed for racing. “The Skechers AERO Elite is the culmination of years of elite-level running innovation—our most technically advanced running shoe to date and a direct statement of intent as we look ahead to the 2028 Summer Games in Los Angeles,” said Catherine Zou,

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