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# Rigel Pharma NDA for Fostamatinib
- URL: https://www.fdaweb.com/rigel-pharma-nda-for-fostamatinib/
- Published: 2017-04-17T12:00:00.000Z
- Updated: 2026-09-14T22:17:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138466

Rigel Pharmaceuticals has submitted an NDA for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP). The submission is supported by data from a Phase 3 clinical program for fostamatinib in ITP, comprising three studies — two randomized placebo-controlled studies (Studies 047 and 048) and an open-label extension study (Study 049). In total, data from 163 ITP patients have been evaluated and included in the NDA submission. Previously, FDA granted an orphan drug designation for the indication.