NDA Filed for Tavalisse for Immune Thrombocytopenia Treatment

The submission includes data from three Phase 3 clinical studies, which contained a total of 163 ITP patients
The submission includes data from three Phase 3 clinical studies, which contained a total of 163 ITP patients

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Tavalisse (fostamatinib disodium; Rigel Pharmaceuticals), for use in patients with chronic or persistent immune thrombocytopenia (ITP).

Tavalisse is an oral treatment designed to inhibit SYK kinase, a key signaling member in the immune process that leads to platelet destruction in ITP. The NDA submission includes data from three Phase 3 clinical studies, which contained a total of 163 ITP patients.

“If approved, we believe Tavalisse will provide a new treatment option for patients with chronic or persistent ITP. We look forward to working closely with the FDA as they review our submission,” said Raul Rodriguez, Rigel's president and chief executive officer. 

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Currently approved therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy.  

The company has identified the date of April 17, 2018, for the FDA to complete its review under the Prescription Drug User Fee Act (PDUFA). The FDA previously granted Orphan Drug designation to Tavalisse for the treatment of patients with ITP.

For more information visit Rigel.com.