FDA Accepts sNDA for Incyte's Jakafi

The results of ruxolitinib's RESPONSE trial were recently presented at ASCO's annual meeting.

Incyte Corporation today announced that the U.S. (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for ruxolitinib as a potential treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. The sNDA includes results from the RESPONSE Phase III trial, which were recently presented at the 2014 American Society of Clinical Oncology (ASCO) annual meeting. RESPONSE was conducted under a Special Protocol Assessment (SPA) from the FDA.

The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ruxolitinib is set for December 5, 2014.

“We are pleased to have received the acceptance of our sNDA filing by the FDA, and we believe that the submission contains a robust data set,” stated Richard Levy, M.D., Executive Vice President and Chief Drug Development and Medical Officer of Incyte. “We look forward to working with the FDA to complete its review of this application”.

Source: MarketWatch