FDA Approves Treatment for for Chronic Immune Thrombocytopenia

Officials with the FDA have approved fostamatinib disodium hexahydrate (Tavalisse, Rigel) for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

The only other approved therapies for ITP are steroids, blood platelet productions boosters, and splenectomy, but there remained a significant need for additional options, as many patients achieve benefit from them.

"Chronic ITP is challenging to treat because the heterogeneity of the disease makes it difficult to predict how an individual patient will respond to available treatments and not all patients can find a treatment that works well for them," James Bussel, MD, the professor emeritus of pediatrics at Weill Cornell Medicine, said in statement

. "The FDA approval of fostamatinib arms physicians with a new treatment option, which works via a novel mechanism."

Bussel, who served as a consultant and paid member of the advisory board for Rigel Pharmaceuticals, Inc, was also the principal study investigator on the FIT Phase 3 program, consisting of 2 phase 3 clinical trials which the FDA utilized to make its decision.

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