Business Wire

Chugai's Satralizumab Receives FDA Breakthrough Therapy Designation for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Jaa

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Chugai’s anti-interleukin-6 (IL-6) receptor humanized recycling antibody satralizumab, an investigational medicine for neuromyelitis optica and neuromyelitis optica spectrum disorders (NMO/NMOSD).

“Satralizumab is a recycling antibody created utilizing Chugai’s proprietary antibody engineering technologies. We are delighted by the FDA’s designation for this innovative antibody based on the results of a Chugai-initiated global Phase III study” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “Satralizumab is designed to inhibit signaling of the inflammatory cytokine IL-6, which is known to play a role in the pathogenesis of NMO/NMOSD. We continue our efforts to hopefully bring satralizumab as a new treatment option as soon as possible to people living with this devastating disease with no approved drugs.”

The designation for satralizumab is based on data from the Phase III study (SAkuraSky study, NCT02028884) evaluating satralizumab added to baseline therapy. This is the seventh Breakthrough Therapy Designation received for four drugs created by Chugai.

[Reference]
Press release issued on October 15, 2018
Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018
https://www.chugai-pharm.co.jp/english/news/detail/20181015120001_561.html

About Breakthrough Therapy

Breakthrough Therapy Designation was adopted as part of the FDA Safety and Innovation Act (FDASIA) enacted in July 2012 aiming at expediting the development and review of drugs for the treatment of severe or life-threatening diseases or symptoms. In order to grant Breakthrough Therapy Designation, preliminary clinical evidence is required demonstrating that the drug may have substantial improvement on at least one clinically significant endpoint over existing therapies. Breakthrough Therapy Designation includes the features of a Fast Track designation, with the addition of intensive guidance on efficient drug development as well as organizational commitment from FDA.

About Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis optica spectrum disorder (NMOSD) is a rare, lifelong, and debilitating autoimmune disease of the central nervous system (CNS) characterized by inflammatory lesions in the optic nerves and spinal cord. 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, and loss of quality of life. In some cases, attacks of NMOSD result in death.

NMOSD pathogenesis is thought to involve AQP4-IgG autoantibody entry into the CNS, however approximately one-third of patients with NMOSD are AQP4-IgG seronegative1)-4). The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis.

Diagnostic criteria introduced in 2006 for neuromyelitis optica 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 was further revised to include a broader spectrum of disease. The diagnostic term NMOSD is now widely used5).

About Chugai

Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area.
In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.
The consolidated revenue in 2017 of Chugai totalled 534.2 billion yen and the operating income was 103.2 billion yen (IFRS Core basis).
Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.

 
References
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. Wingerchuk DM, Banwell B, Bennett JL et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology 2015;85:177-89.
 

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 France SAS
Nathalie Leroy
Tel: +33-1-56-37-05-21
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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Fishawack continues to build best-in-class service offering with Dudnyk acquisition20.3.2019 16:00:00 EETTiedote

Fishawack, a leading independent healthcare communications specialist, is excited to announce its acquisition of Dudnyk, the Philadelphia-based healthcare communications agency. Dudnyk is an award-winning, full-service agency that specializes in creating insight-driven, authentic brand experiences that unite specialty physicians and their patients. They leverage strategic, scientific, and creative capabilities to serve clients in the biotech, pharmaceutical, and medical device industries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190320005204/en/ Dudnyk leadership team includes Christopher Tobias, PhD, President; Laurie Bartolomeo, EVP, Creative Director; Drew Desjardins, EVP, Chief Strategy Officer; Annemarie Armstrong, EVP, Director of Client Services; John Kemble, EVP, Creative Producer. (Photo: Business Wire) Fishawack’s goal is to increase the range of healthcare communications services that it can offer to commerc

ExaGrid Nominated in Six Categories for the 2019 Network Computing Awards20.3.2019 15:00:00 EETTiedote

ExaGrid ®, a leading provider of intelligent hyperconverged storage for backup, today announced that it has been nominated in six categories for the 2019 Network Computing Awards. ExaGrid has become a finalist for Data Centre Product of the Year, The Return on Investment Award, Hardware Product of the Year, Product of the Year, The Customer Service Award, and Company of the Year. Voting to determine the winner in each category is underway now and closes on April 23. The results will be revealed at an evening award ceremony in London on May 2. ExaGrid’s model EX63000E backup storage appliance with data deduplication is a nominee in four categories. The model provides the largest scale-out system and offers up to a 2PB full backup with an ingest rate of 432TB/hr, which is three times faster than any other backup storage on the market. “We are thrilled to be nominated by IT staff, and recognized by Network Computing, in six prestigious categories this year,” said Bill Andrews, CEO and Pre

Eos Biosciences Issued Patent for New Approach to Shuttle Therapeutics Across the Blood-Brain Barrier to Treat Brain Diseases20.3.2019 14:30:00 EETTiedote

Eos Biosciences, Inc. (Eos), a nanomedicines company developing an efficient and versatile nanobiologic particle-based platform technology (Eosomes), announced that the U.S. Patent and Trademark Office has granted Eos Biosciences Patent No. 10,183,078, relating to a novel approach of using HER3-targeted Eosomes as a shuttle system for transporting various classes of therapeutics across the blood-brain barrier for treatment of brain disorders, including brain cancer. The patent is owned by Cedars-Sinai Medical Center and is exclusively licensed to Eos Biosciences. Details of the system will be highlighted in an upcoming manuscript from Lali Medina-Kauwe, PhD, Professor, Department of Biomedical Sciences, Cedars-Sinai. Omar Haffar, Ph.D., Founder, President and Chief Executive Officer, commented, “We’re very excited by the issuance of this pivotal patent and look forward to receiving similar approvals in other countries. This patent adds to Eos’ considerable IP portfolio covering the Eos

Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics20.3.2019 13:45:00 EETTiedote

Vivet Therapeutics (“Vivet”), a privately held gene therapy biotech company dedicated to developing gene therapy treatments for inherited liver disorders with high unmet medical need, and Pfizer Inc. (NYSE: PFE) announced today that Pfizer has acquired a 15% equity interest in Vivet and secured an exclusive option to acquire all outstanding shares. Pfizer and Vivet will collaborate on the development of VTX-801, Vivet’s proprietary treatment for Wilson disease. Wilson disease is a devastating, rare, chronic, and potentially life-threatening liver disorder of impaired copper transport that causes serious copper poisoning. In patients with Wilson disease, a monogenetic mutation disables the normal copper biliary excretion pathway leading to excess copper accumulation in the liver and other organs including the central nervous system. Untreated, Wilson disease results in various combinations and severity of hepatic (fibrosis and cirrhosis), neurologic and psychiatric symptoms, which can b

Fintech Company Rimilia Appoints Kevin Kimber as CEO20.3.2019 13:00:00 EETTiedote

Rimilia, a fintech company helping finance departments simplify the complex, has appointed Kevin Kimber as CEO. The news follows another strong year for Rimilia. In 2018, Rimilia opened offices in Central London and Denver, Colorado in the U.S., and reported significant revenue growth on the previous year. Rimilia was founded in 2008 and its platform, created by finance professionals, uses RPA (robotic process automation) technology to help finance teams fast-track their cash flow by providing clearer information and better control. It has quickly become the industry leader, trusted by a number of global brands from HSBC to DHL and Santander, to provide visibility, improve efficiencies and guarantee cash flow. Rimilia works with any currency, any bank and in any language, and on average delivers 70% cost-savings and an 80% reduction in manual effort to its customers. Kevin joins Rimilia from Eight Roads Ventures (one of Rimilia’s investors), where he was a Venture Partner, advising its

Knopp Biosciences Enters Collaboration with Leading UK Investigators to Commence Phase 2 Clinical Trial of Dexpramipexole in Severe Eosinophilic Asthma20.3.2019 13:00:00 EETTiedote

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with high unmet need, today announced a collaboration with a consortium of leading medical researchers in the United Kingdom to evaluate the ability of Knopp’s lead drug candidate, dexpramipexole, to reduce exacerbations in people with severe eosinophilic asthma. The project is chiefly funded by the National Institute for Health Research (NIHR) and Medical Research Council (MRC) of the UK. The Chief Investigator for the Phase 2 multi-center, 52-week trial is Professor Salman Siddiqui, Professor of Airway Diseases at the University of Leicester and Consultant Respiratory Physician at Leicester’s Hospitals. Dexpramipexole is an orally available small molecule shown to selectively reduce eosinophil levels in multiple clinical trials, including in a Phase 2 study in hypereosinophilic syndrome (HES) and a Phase 2 trial in chr

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme