Unexpected FDA delay for Incyte's Jakafi sNDA

The US Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids, Incyte (Nasdaq: INCY) revealed yesterday

The new Prescription Drug User Fee Act (PDUFA) target action date is May 24, 2019. Incyte’s shares closed down 1.95% at $79.83 yesterday.

The FDA extended the action date to allow time to review additional data submitted by Incyte in response to the FDA’s information requests, Incyte noted. 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.