U.S. FDA Grants Priority Review for Fedratinib - New Drug Application in Myelofibrosis
In a press release published today, Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has granted a Priority Review for Fedratinib, a possible new drug for the treatment of Myelofibrosis.
“The acceptance of the NDA and granting of Priority Review for fedratinib represent the first potential new treatment option after many years for patients affected by myelofibrosis,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “Patients with myelofibrosis, including the number who are ineligible for or failed existing therapy continues to increase, representing a well-defined unmet medical need. We believe fedratinib can play an important role in the treatment of myelofibrosis and we look forward to working with the FDA as the review process advances.”