On December 8, 2017 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that the one-year efficacy and safety results from its FIT Phase 3 clinical program of fostamatinib for chronic or persistent immune thrombocytopenia (ITP) will be featured in an oral presentation at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held in Atlanta, GA from December 9 to December 12, 2017 (Press release, Rigel, DEC 8, 2017, View Source;p=RssLanding&cat=news&id=2321827 [SID1234522471]).
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During the presentation, James B. Bussel, M.D., professor emeritus of pediatrics at Weill Cornell Medicine and the principal study investigator on the FIT Phase 3 program who has served as a member of an advisory/scientific board for Rigel Pharmaceuticals, will share an overview of the FIT clinical program.
Oral Presentation Details:
TITLE: Long-Term Maintenance of Platelet Responses in Adult Patients with Persistent/Chronic Immune Thrombocytopenia Treated with Fostamatinib: 1-Year Efficacy and Safety Results
Session Name: 311. Disorders of Platelet Number or Function: ITP: clinical aspects
Session Date: Saturday, December 9, 2017
Session Time: 7:30 AM – 9:00 AM EST
Presentation Time: 8:15 AM EST
Location: Georgia World Congress Center, Bldg B, Lvl 3, B304-B305 (Atlanta, GA)
About Fostamatinib in ITP
Fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, is an investigational drug for adult patients with chronic or persistent immune thrombocytopenia (ITP). The New Drug Application (NDA) for fostamatinib for adult patients with chronic or persistent ITP, which was previously granted Orphan Drug designation, is currently under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2018. The conditionally approved proprietary name for fostamatinib (as confirmed by the FDA) is TAVALISSETM.
The NDA is supported by data from the FIT Phase 3 clinical program, which was comprised of three studies, two randomized placebo-controlled studies (Studies 047 and 048) and an open-label extension study (Study 049). Together with an initial proof of concept study, the NDA included 163 ITP patients. Across all indications, fostamatinib has been evaluated in over 4,600 subjects. Data from all studies, including preclinical evaluation and drug manufacturing data, were included in the NDA submission.
About ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with increased risk of severe bleeding events that can result in serious medical complication, or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.