US FDA grants Priority Review for fedratinib NDA

The US Food and Drug Administration has accepted the New Drug Application (NDA) for fedratinib and granted a Priority Review to the filing submitted by US biotech major Celgene (Nasdaq: CELG).

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. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set its action date as September 3, 2019.

Celgene, itself the subject of a $74 billion takeover bid from Bristol-Myers Squibb (NYSE: BMY), acquired rights to fedratinib along with its buy in January 2018 of Impact Biomedicines, which acquired rights from Sanofi (Euronext: SAN) in 2016.