FDA extends PDUFA date for Jakavi to treat acute graft-versus-host disease.- Incyte + Novartis

Incyte announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids. The new Prescription Drug User Fee Act (PDUFA) target action date is 24 May 2019.

The FDA extended the action date to allow time to review additional data submitted by Incyte in response to the FDA�s information requests. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the sNDA, resulting in an extension of the PDUFA goal date by three months.