Celgene Says FDA Grants Priority Review For Fedratinib NDA In Myelofibrosis

(RTTNews) - Celgene Corp. (CELG) said Tuesday that the U.S. Food and Drug Administration has accepted the company's New Drug Application or 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. Under the Prescription Drug User Fee Act, the FDA has set its action date as September 3, 2019.

Fedratinib is an investigational compound that is not approved for any use in any country.

Celgene noted that the NDA for fedratinib is based on results from a randomized, placebo-controlled, phase 3 trial (JAKARTA) in patients with primary or secondary myelofibrosis, as well as a single-arm, open-label phase 2 trial (JAKARTA2) in patients with primary or secondary myelofibrosis previously exposed to ruxolitinib, the only FDA-approved treatment for the disease.

Results of these two trials were previously published in peer-reviewed journals. The FDA has also provided fedratinib Orphan Drug designation for the treatment of secondary and primary myelofibrosis.

Celgene said it also plans to evaluate fedratinib in combination with luspatercept.