> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Rigel Pharma ITP Therapy Approved
- URL: https://www.fdaweb.com/rigel-pharma-itp-therapy-approved/
- Published: 2018-04-18T12:00:00.000Z
- Updated: 2026-09-14T23:59:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141249

FDA has approved a Rigel Pharmaceuticals NDA for Tavalisse (fostamatinib disodium hexahydrate) for treating thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The oral spleen tyrosine kinase inhibitor is designed to target the underlying autoimmune cause of the disease by blocking platelet destruction.

Approval was based on data from the company’s FIT clinical program, which included two randomized placebo-controlled Phase 3 trials (Studies 047 and 048) and an open-label extension (Study 049). The studies involved 163 ITP patients and the NDA was supported by a safety database of more than 4,600 subjects across other indications in which fostamatinib has been evaluated, according to the company.