Rigel Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to fostamatinib for the treatment of patients with chronic immune thrombocytopenic purpura (ITP).
Fostamatinib is currently in Phase 3 clinical trials for ITP and in Phase 2 clinical trial for IgA nephropathy (IgAN). Rigel’s Phase 3 program, FIT, has surpassed the half-way point in enrollment and is expected to announce results in mid-2016. It is an oral spleen tyrosine kinase (SYK) inhibitor.
Raul Rodriguez, president and chief executive officer of Rigel, said that the company intends to file a New Drug Application (NDA) with the FDA for fostamatinib to treat ITP.
For more information call (650) 624-1100 or visit Rigel.com.