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FDA accepts new drug application for Tavalisse to treat immune thrombocytopenia

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The FDA accepted the new drug application for fostamatinib disodium, an oral investigational drug candidate in development to treat patients with chronic or persistent immune thrombocytopenia.

Fostamatinib disodium (Tavalisse, Rigel Pharmaceuticals) is designed to inhibit the spleen tyrosine kinase.

The FDA’s acceptance is supported by data from a phase 3 clinical program that included three studies — two randomized, placebo-controlled studies and an open-label extension study — that evaluated fostamatinib disodium in 163 patients with immune thrombocytopenia (ITP).

The new drug application included data from all studies, including preclinical evaluation and drug manufacturing data.

“The FDA acceptance for filing of our new drug application is an exciting milestone for Rigel,” Raul Rodriguez, president and CEO of Rigel Pharmaceuticals, said in a company-issued press release. “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.”

The FDA set an action date of April 17, 2018.