Posted by Michael Wonder on 06 Mar 2019
U.S. FDA grants priority review for fedratinib new drug application in myelofibrosis
5 March 2019 - U.S. FDA sets Prescription Drug User Fee Act action date for 3 September 2019.
Celgene Corporation today announced the U.S. FDA has accepted the company’s new drug application 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.
The application 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.
