FDA Accepts NDA for Fostamatinib Disodium


Manufacturer Rigel Pharmaceuticals expects an FDA decision by April, 2018.

The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for the use of fostamatinib disodium (TAVALISSE) in patients with chronic or persistent immune thrombocytopenia (ITP).

The drug is manufactured by San Francisco-based Rigel Pharmaceuticals, who said in a statement that they expect the FDA to complete its review by April 17, 2018.

“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.

The NDA was supported by data from the phase III clinical program for fostamatinib disodium in patients with ITP. Across all indications, the drug was evaluated in more than 4,600 patients.

“Currently approved therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients derive a benefit from existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP,” the statement read.

Fostamatinib disodium is an oral investigational drug candidate designed to inhibit SKY kinase, a key signaling member in the immune process that leads to platelet destruction in ITP. The drug may address an underlying autoimmune cause of ITP by impeding platelet destruction, unlike other therapies that modulate the immune system or stimulate platelet production, the statement read.

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