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Idhifa Approval History

FDA Approved: Yes (First approved August 1, 2017)
Brand name: Idhifa
Generic name: enasidenib
Dosage form: Tablets
Company: Celgene Corporation
Treatment for: Acute Myeloid Leukemia

Idhifa (enasidenib) is a first-in-class, oral, targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.

Development History and FDA Approval Process for Idhifa

DateArticle
Aug  1, 2017Approval FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation
Jun  6, 2017Updated Data from Phase 1 Trial of Oral IDHIFA® (enasidenib) Demonstrate Complete Responses and Duration of Response in Patients with Relapsed or Refractory AML and an IDH2 Mutation
Mar  7, 2017FDA Accepts New Drug Application and Grants Priority Review for Enasidenib in Relapsed or Refractory AML with an IDH2 Mutation

Further information

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