CHUGAI-PHARMACEUTICAL
Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that Roche has received notification that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 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).
“We are pleased that Enspryng is expected to be approved in the EU for the treatment of NMOSD, a disease with limited treatment options that causes visual impairment and neurological disability,” said Chugai’s President and CEO, Dr. Osamu Okuda. “Enspryng is effective in the prevention of NMOSD relapses and well tolerated in people with AQP4-IgG seropositive NMOSD as shown in two global phase III studies. Enspryng is expected to be the first approved product in the EU to apply our proprietary recycling antibody technology, and the first NMOSD treatment targeting the IL-6 receptor to enable people with NMOSD to be treated at home by self-injection* through subcutaneous administration.”
Enspryng has been evaluated for efficacy and safety in clinical trials in NMOSD including people who have only experienced a single NMOSD attack and adolescents, and is expected to be approved in the EU. The positive recommendation 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 20 countries including Japan and the United States.
The impact on the consolidated financials for the fiscal year ending December 2021 of Chugai is expected to be negligible.
*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]
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
• SAkuraSky study
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)
https://www.chugai-pharm.co.jp/english/news/detail/20191129110000_644.html
• SAkuraStar study
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)
https://www.chugai-pharm.co.jp/english/news/detail/20200424150001_714.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 . 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 accepted 11 .
Trademarks used or mentioned in this release are protected by law.
Sources
1. Neuromyelitis optica spectrum disorder (NMOSD) Online. https://nmosd-online.jp/
Accessed March 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.
11. Wingerchuk DM, Banwell B, Bennett JL et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology 2015;85:177-89.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210425005007/en/
Link:
About Business Wire
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
SCENTMATIC's AI "KAORIUM" Debuts at THAMEEN Fragrance Launch in London's Selfridges4.7.2025 11:13:00 CEST | Press release
SCENTMATIC Inc., a leader in scent digitalization, introduced its AI-powered scent-to-language system, KAORIUM, at the THAMEEN Fragrance new product launch event. This pivotal event took place from June 5 to 11, 2025, at Selfridges department store in London, UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703662207/en/ State of exhibition Global Expansion: KAORIUM Establishes UK Presence Europe leads the global fragrance market, with the UK projected to reach US$2.82 billion by 2033. Recognizing this, SCENTMATIC is rapidly expanding its international footprint. In May 2024, SCENTMATIC established its overseas subsidiary, KAORIUM, in London, appointing industry expert Ben Yanoushek as CEO. Official UK operations commenced on February 1, 2025, with the launch of its dedicated website: www.kaorium.com. KAORIUM Trialed at "Florentine Diamond" Launch Event The "Florentine Diamond" launch event for luxury brand THAMEEN Frag
Andersen Consulting samarbejder med Mercurial Minds om at forbedre mulighederne inden for digital transformation4.7.2025 01:10:00 CEST | Pressemeddelelse
Andersen Consulting udvider sit udbud af teknologidrevne løsninger med tilføjelsen af samarbejdsfirmaet Mercurial Minds (M.M.), et konsulentfirma inden for digital transformation, AI og IT med base i Pakistan. M.M. blev grundlagt i 2013 og tilbyder en række tjenester, der er designet til at hjælpe organisationer med at udvikle sig og skalere, herunder i forbindelse med deres digitale transformationsstrategi, AI-tjenester, it-rådgivning og udvikling af robuste mobil- og webbrugeroplevelser. Firmaet leverer end-to-end-løsninger – udformning af datadrevne køreplaner, udvikling af intelligent automatisering og levering af sikre mobil- og weboplevelser, der kan skaleres – skræddersyet til virksomheder, der ønsker at forbedre sine forbindelsesmulighederne og opnå indsigter i realtid. M.M. betjener en bred vifte af brancher med fokus på finans, telekommunikation og andre dataintensive sektorer. "Dette samarbejde er en katalysator," siger Nabeel Saiyer, administrerende direktør for M.M. "Vores
Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 01:00:00 CEST | Press release
The World Economic Forum report, in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, predicts a significant uptick in tourist trips across the globeThe tourism sector will contribute $16 trillion to global GDP (more than 11% of the global economy) by 2034, according to World Travel & Tourism Council estimates (WTTC)India and China will be responsible for more than 25% of all outbound travel by 2030 The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster th
The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 21:00:00 CEST | Press release
The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate
Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 14:59:00 CEST | Press release
Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets 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