Incyte Says FDA Issued CRL For Ruxolitinib Extended-release Tablets

(RTTNews) - Incyte Corp. (INCY) announced Friday that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).

The complete response letter states that the FDA cannot approve the application in its present form. The FDA acknowledged that the study submitted in the New Drug Application (NDA) met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.

Incyte intends to meet with the FDA to determine appropriate next steps.

The NDA was based on two studies designed to show that ruxolitinib XR tablets are dosage strength proportional and bioequivalent to Jakafi (ruxolitinib) tablets.