U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis

SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG) today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for fedratinib and granted a Priority Review. Fedratinib is a highly selective JAK2 inhibitor intended for the treatment of patients with myelofibrosis, a serious bone marrow disorder that disrupts the body’s normal production of blood cells.1 Under the Prescription Drug User Fee Act, the FDA has set its action date as Sept. 3, 2019.