FDA accepts NDA for fedratinib to treat myelofibrosis

Celgene Corporation announced the 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.

Under the Prescription Drug User Fee Act, the FDA has set its action date as 3 September, 2019. The NDA for fedratinib is based on results from a randomized, placebo-controlled, phase III trial (JAKARTA)in patients with primary or secondary myelofibrosis, as well as a single-arm, open-label phase II 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 have been previously published in peer-reviewed journals. The FDA has also provided fedratinib Orphan Drug designation for the treatment of secondary and primary myelofibrosis. Celgene also plans to evaluate fedratinib in combination with luspatercept.