Chugai’s Enspryng (Satralizumab) Receives Regulatory Approval from FDA for Neuromyelitis Optica Spectrum Disorder
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
Results from Phase III SAkuraSky Study for Chugai’s Enspryng in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online (November 29, 2019)
Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Enspryng in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology (April 24, 2020)
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.
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.
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
For US media
Chugai Pharma USA Inc.
For European media
Chugai Pharma U.K. Ltd.
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Rimini Street Celebrates 15 Years of Delivering Client Success28.9.2020 15:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of business software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that September marks the 15th anniversary of the Company’s founding in 2005 to redefine the enterprise software support market. The Company set out to deliver a premium, ultra-responsive support model, and bring choice and value to software licensees around the world. Since its inception, Rimini Street has continually set the premium standard on what Oracle and SAP licensees should expect from their support experience. The Company is responsible for delivering a long history of innovative “firsts” for the enterprise software support market, including guaranteed ultra-responsive SLA’s, support for customizations at no additional cost, support for at least 15 years without required upgrades or updates and saving clients nearly $5 billion in total maintenance and support cos
Epic Fantasy 3DMMORPG Forsaken World: Gods and Demons Open for Pre-registration Today28.9.2020 15:00:00 CEST | Press release
Forsaken World: Gods and Demons is an open-world fantasy MMORPG on an incredible scale. Dive into a world of never-ending adventure where treasure and glory awaits the victor. Raid a dragon's lair, search for lost artifacts, or kick back, relax and catch some fish in between epic adventures. The world around you will be influenced by your in-game decisions, with a storyline that allows you to determine the future of Calindor. Leave your mark and become a legend! This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200928005293/en/ Pre-register now on the App Store and Google Play (Graphic: Business Wire) Endless Character Customization Change your class at any time and specialize your character just the way you want it. Mix and match abilities and talents to fit your combat style, and customize your appearance to bring out the true you, right down to the facial expression. No two players are the same in FW: GD. A Stunning World Im
Hyprevention Raises New Financing to Commercialize Spinal Implant Product V-STRUT© in the USA.28.9.2020 14:55:00 CEST | Press release
Hyprevention has raised new financing to support the V-STRUT© Vertebral Implant product. The financing will be used to execute the commercialization plans for the US spinal fracture market. The V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures. In May 2019, a US patent was granted for V-STRUT© and in March 2020, the device received FDA-510(k) clearance. “We are delighted that our existing investors have shown confidence in our product development efforts and commercialization plans for the US market by increasing their investment in the company,” says Cecile Vienney, CEO. The Hyprevention team has entered into a commercial relationship with DAWA Medical and has received several orders for the product from enthusiastic customers. DAWA Medical, a regional distributor of medical products, will promote sales in Florida, Illinois, Texas and Oklahoma. In addition to DAWA the company is in discussion with other commercial partners to bring the innovative
Mavenir acquires ip.access to expand OpenRAN radio portfolio for CSPs and Enterprise Private Networks28.9.2020 14:00:00 CEST | Press release
Mavenir, a leading provider of end-to-end cloud-native Network Software Provider for Communications Service Providers (CSPs) announces today that it has acquired ip.access Ltd, a leading 2G, 3G, 4G and 5G-ready small cell solutions provider. This acquisition extends Mavenir’s leadership in OpenRAN radio on three fronts: Communication Service Providers: Adding 2G and 3G capabilities to the OpenRAN portfolio Enterprise: Adding a full suite of enterprise radio solutions for Mavenir’s Private Network offerings, including OnGo/CBRS certified solutions Nontraditional Networks: Leveraging market leading software defined vRAN solutions for Aviation, Maritime, Rural and Remote networks with next generation solutions in the air, on land and at sea. “Operators are looking to transform their 2G/3G networks as they migrate to 4G and 5G,” said Pardeep Kohli, President and CEO, Mavenir. “We expect to provide a seamless, multi radio access technology single RAN offering for those operators that allows
PCI Pharma Services Introduces First-of-its-Kind Digital Platform to Provide Clients with Real-Time Supply Chain Data and Analytics28.9.2020 12:00:00 CEST | Press release
PCI Pharma Services (PCI), a leading pharmaceutical and biopharmaceutical global outsourcing solutions provider today announced the launch of pci | bridge, an innovative digital platform that will give customers immediate visibility into their clinical and commercial supply chain, and provide instantaneous data and insights to inform decision-making. Created using an agile development process whereby key clients collaborated and provided input, PCI built an industry-leading digital interface that delivers greater transparency to clients – saving time and resources to ultimately help bring life-changing therapies to patients faster. The launch of pci | bridge is one of many initiatives that PCI has undertaken to incorporate digital transformation as core to its business strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200928005059/en/ pci | bridge digital platform logo (Photo: Business Wire) “At PCI, we are always loo
MILAN AIRPORTS MALPENSA & LINATE FIRST IN ITALY TO DEPLOY ECAC STANDARD 3 CABIN BAGGAGE SCREENING SYSTEMS WITH SMITHS DETECTION28.9.2020 11:00:00 CEST | Press release
Smiths Detection today announced that it has been awarded a contract by SEA Group to support the upgrade of Malpensa and Linate Airports, two of the three international airports in Milan, to the highest security standard for cabin baggage in the industry - ECAC EDS CB C3. As part of the implementation, up to 18 advanced Computed Tomography (CT) screening systems — HI-SCAN 6040 CTiX — will be installed at Milano Malpensa Airport Terminal 1 along with up to 10 more at Milano Linate Airport. Besides providing advanced explosives detection with low false alarm rates, the CT technology allows electronic devices and liquids to remain in bags. SEA Group also selected Smiths Detection’s HI-SCAN 6040 CTiX carry-on baggage scanners to help protect the health of travellers by reducing the number of trays required during security screening and minimising points of contact at security lanes. “As key gateways to the rest of the world for Milan, our priority for Malpensa and Linate airports is to pro