Rigel Pharma: FDA To Review NDA For TAVALISSE - Quick Facts

(RTTNews) - Rigel Pharmaceuticals, Inc. (RIGL) announced the U.S. FDA has filed its New Drug Application for the use of TAVALISSE (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia. 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, and an open-label extension study.

Rigel expects the action date for the FDA to complete its review will be April 17, 2018, under PDUFA. The FDA previously granted Orphan Drug designation to TAVALISSE for the treatment of patients with immune thrombocytopenia.