Enasidenib NDA accepted for Priority Review by FDA

The New Drug Application (NDA) for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation has been accepted by the US Food and Drug Administration.

The drug is being developed by US biotech major Celgene (Nasdaq: CELG) and Agios Pharmaceuticals (Nasdaq: AGIO), and the news that the NDA has been  granted Priority Review and given a Prescription Drug User Fee Act (PDUFA) action date of August 30, 2017 sent Agios share 6.8% higher to $51.74 by close of trading on Wednesday. Celgene completed the NDA submission in late December 2016.

“We accelerated this application – submitting the NDA just three years after the first patient was treated in the enasidenib pivotal investigational trial – because we believe that there is a significant unmet need for people with relapsed or refractory AML,” said Michael Pehl, president, Hematology/Oncology for Celgene. “The acceptance of the enasidenib NDA is a significant milestone in what we hope will be a new era of molecularly targeted therapies for patients with this devastating disease,” he noted.