FDA Accepts Rigel's New Drug Application for TAVALISSE™ (fostamatinib disodium) for the Treatment of Chronic ITP
- Category: Small Molecules
- Published on Monday, 19 June 2017 14:55
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SOUTH SAN FRANCISCO, CA, USA I June 19, 2017 I Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced the U.S. Food and Drug Administration (FDA) has filed its New Drug Application (NDA) for the use of TAVALISSE™ (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia (ITP). Rigel expects the action date for the FDA to complete its review will be April 17, 2018, under the Prescription Drug User Fee Act (PDUFA). The FDA previously granted Orphan Drug designation to TAVALISSE™ for the treatment of patients with ITP.
"The FDA acceptance for filing of our NDA is an exciting milestone for Rigel," said Raul Rodriguez, Rigel's president and chief executive officer. "If approved, we believe TAVALISSE™ will provide a new treatment option for patients with chronic or persistent ITP. We look forward to working closely with the FDA as they review our submission."
The NDA submission is supported by data from the Phase 3 clinical program for fostamatinib in ITP, 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.
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. Currently approved therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients derive a benefit from existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
About TAVALISSE™ (fostamatinib disodium)
TAVALISSE™ is an oral investigational drug candidate designed to inhibit SYK kinase, a key signaling member in the immune process that leads to platelet destruction in ITP. Unlike other therapies that modulate the immune system in different ways or stimulate platelet production, fostamatinib may address an underlying autoimmune cause of ITP by impeding platelet destruction.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematological disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's current clinical programs include clinical trials of fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in a number of indications. Rigel has submitted an NDA to the FDA for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP). In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo and Aclaris Therapeutics.
SOURCE: Rigel Pharmaceuticals