Rigel Pharmaceuticals Plans Not to File Fostamatinib sNDA Following FDA Feedback
Rigel Pharmaceuticals decided to not file a supplemental New Drug Application (sNDA) for fostamatinib in the treatment of patients with warm autoimmune hemolytic anemia, an autoimmune disorder that includes premature destruction of healthy red blood cells.
The company decision follows FDA feedback. The phase 3 trial results also did not help make the case for this drug, which did not demonstrate statistical significance in durable hemoglobin response in the overall study population.
Fostamatinib is FDA-approved as Tavalisse (fostamatinib disodium hexahydrate) for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
Tavalisse is an oral spleen tyrosine kinase inhibitor.
Shares of Rigel were lower in Monday's late-trading session, after the company said it received "guidance from the U.S. Food and Drug Administration's review of the company's re-analysis of data from the FORWARD Phase 3 trial of fostamatinib for the treatment of patients with warm autoimmune hemolytic anemia."
About Rigel Pharmaceuticals Inc.
Rigel Pharmaceuticals is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Founded: 1996, Headquarters: South San Francisco, California, United States. CEO: Raul R. Rodriguez.
October 13, 2022
