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Agios Pharmaceuticals inc announces orphan drug designation of AG-221 for treatment of Acute Myelogenous Leukemia


Monday, 16 Jun 2014 08:00am EDT 

Agios Pharmaceuticals Inc:U.S. Food and Drug Administration (FDA) has granted company orphan drug designation for AG-221 for treatment of patients with acute myelogenous leukemia (AML).AG-221 is an oral, first-in-class IDH2 mutant inhibitor being evaluated in a Phase 1 clinical trial in patients with advanced hematologic malignancies that carry an IDH2 mutation.FDA's Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in U.S. Orphan drug designation provides to Agios.Says its collaborator Celgene certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials. 

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19 Dec 2014