Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor which is currently in Phase 3 clinical studies in patients with chronic immune thrombocytopenic purpura (ITP). Rigel's Phase 3 program for Fostamatinib in ITP, called FIT, has surpassed the half-way point in enrollment and Rigel expects the program to read out results in mid-2016.
"Receiving this Orphan Drug designation from the FDA is a positive step forward in the development of Fostamatinib," said Raul Rodriguez, president and chief executive officer of Rigel. "We look forward to completing our Phase 3 program and intend to file a New Drug Application for Fostamatinib in ITP in the U.S.," he added.
Fostamatinib and 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. ITP patients can suffer extraordinary bruising, bleeding and fatigue as a result of low platelet counts. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. Rigel believes that Fostamatinib may address the autoimmune basis of the disease.
Rigel Pharmaceuticals, Inc.