CHMP recommends approval of Tavalisse in chronic immune thrombocytopenia.- Rigel Pharma

Rigel Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive trend vote on the Marketing Authorization Application (MAA) for Tavalisse (fostamatinib disodium hexahydrate). The indication for the positive trend vote is for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments. The CHMP intends to hold a final vote on their recommendation at their November meeting.

Comment: Fostamatinib is commercially available in the U.S. and is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in U.S. adult patients with chronic ITP who have had an insufficient response to a previous treatment. Europe is the second largest market for adult chronic ITP treatments after the United States.