FDA approves AML drug Idhifa from Agios and Celgene

FDA approved Idhifa enasidenib (AG-221) from Celgene Corp. (NASDAQ:CELG) and partner Agios Pharmaceuticals Inc. (NASDAQ:AGIO) to treat adults with relapsed or refractory acute myelogenous leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation. Idhifa is an inhibitor of mutated IDH2. FDA concurrently approved the RealTime IDH2 companion diagnostic from Abbott Laboratories (NYSE:ABT).

Celgene spokesperson Brian Gill told BioCentury the monthly wholesale acquisition cost (WAC) of Idhifa is $24,872. Agios said the drug should be available to patients "within the next day or two."...