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

Lattice Expands Secure Control FPGA Leadership with New Lattice Mach-N2 Family17.9.2026 05:00:00 EEST | Press release

Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced Lattice Mach™-N2 FPGA family, extending its long-running secure control FPGA leadership with new devices purpose-built for system control and security in modern infrastructure. Built on the Lattice Nexus™ 2 small FPGA platform, Mach-N2 combines integrated flash, a hardware Root of Trust, and CNSA 2.0-compliant post-quantum cryptography (PQC) with crypto agility for trusted, always-on system control and security across next-generation systems. "The demands on system control and security are accelerating as post-quantum mandates take hold, and customers building long-lifecycle infrastructure seek solutions that will help them design with today and tomorrow’s security needs in mind," said Esam Elashmawi, Chief Strategy and Marketing Officer, Lattice Semiconductor. "Mach-N2 represents a significant step forward in logic density and bandwidth while adding the most complete post-qua

Lattice Advances FPGA Design with New Leadership AI-Driven Development Tool, Lattice Prompt17.9.2026 05:00:00 EEST | Press release

Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today introduced a new leadership AI-powered FPGA development tool for small and mid-range FPGAs that redefines how FPGA developers work across the full design flow. Lattice Prompt pairs with AI agentic tools developers already use, combining them with Lattice design tools, knowledge base, and documentation to turn natural language inputs into validated responses, dramatically accelerating FPGA development while optimizing design performance and capability. "Accelerating time-to-market demands and rising design complexity are putting mounting pressure on FPGA developers to do more with every design cycle," said Esam Elashmawi, Chief Strategy and Marketing Officer, Lattice Semiconductor. "Lattice Prompt gives developers AI-assisted access to the full design flow, grounded in Lattice's validated knowledge, so they can focus on what matters most: building differentiated systems." Lattice Prompt:

TOURISE Unveils 2027 Summit Under the Theme “Alliances That Move the World”16.9.2026 23:53:00 EEST | Press release

Under the patronage of His Royal Highness Mohammed bin Salman bin Abdulaziz Al Saud, Crown Prince and Prime Minister, His Excellency Ahmed Al-Khateeb, Minister of Tourism and Chairman of TOURISE, today announced the TOURISE 2027 Summit, taking place in Riyadh from March 23-25, 2027. Building on the inaugural TOURISE Summit in November 2025 and a year of collaboration since, the 2027 edition will run under the theme “Alliances That Move the World.” Over three days, leaders will focus on the partnerships, investments and actions needed to advance the global tourism agenda over the next 50 years.​ This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916467896/en/ The Summit will convene public and private sector leaders across tourism, technology, investment, sustainability, culture, mobility and government to tackle the sector’s most pressing opportunities and challenges and help shape the next era of global tourism.​ At the inau

Brightfin Names Dan McNamara Chief Customer Officer16.9.2026 20:13:00 EEST | Press release

Brightfin, the leading platform for total spend intelligence in enterprise IT, today announced that Dan McNamara has joined the company as Chief Customer Officer (CCO). The appointment comes as Brightfin extends its platform into a broader vision of financial truth and operational clarity across the entire enterprise technology stack, and as more IT and finance leaders turn to Brightfin to make sense of fast-growing, fragmented spend across cloud, mobile, and emerging AI tooling. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916064892/en/ Dan McNamara, CCO of Brightfin McNamara has built his career on meeting increasingly complex customer expectations. Twice, he has joined a customer organization in the middle of rapid growth and left it with a stronger customer base. As Chief Customer Officer at Apryse, he helped grow annual recurring revenue from $40 million to $250 million while the company completed more than 15 acqu

Jazwares Partners With Sanrio to Expand Its Hello Kitty and Friends Range to EMEA16.9.2026 19:00:00 EEST | Press release

Jazwares, one of the world’s leading toy companies, today announced a licensing agreement with Sanrio GmbH, extending Jazwares successful Hello Kitty and Friends toy line to Europe, the Middle East, and Africa (EMEA). The agreement will bring Sanrio’s beloved Hello Kitty and Friends characters to even more fans in the region through playful, imaginative products designed for kids and collectors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916913201/en/ Jazwares partners with Sanrio to expand its Hello Kitty and Friends range to EMEA Available across key EMEA markets, the collection of trendy plush and figures, playsets, vehicles, and seasonal items reimagines Hello Kitty alongside fan-favorite friends including Cinnamoroll, Kerokerokeroppi, Pompompurin, Tuxedosam, My Melody, Kuromi, Pochacco, Bad Badtz-Maru, and Little Twin Stars. “Hello Kitty and Friends commands a truly multi-generational, global fanbase, cementing i

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