New Drugs Approved in August


Idhifa was approved by the FDA on August 1, 2017 for the treatment of patients with relapsed or refractory acute myeloid leukemia, specifically with an IDH2 mutation. About 8-19% of AML patients carry IDH2 mutation.

Developed by Celgene Corp. (CELG) and Agios Pharmaceuticals Inc. (AGIO), Idhifa is the first and only oral, targeted inhibitor of IDH2.

The drug is to be used with Abbott Laboratories’ RealTime IDH2 Assay, a companion diagnostic, which is used to detect specific mutations in the IDH2 gene in patients with acute myeloid leukemia.

Idhifa, which is taken as a pill, once a day, is a novel drug. The monthly list price of the drug is $24,872.