Incyte Corporation Release: FDA Accepts Supplemental New Drug Application For Jakafi® (Ruxolitinib) And Priority Review Granted

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (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.

Help employers find you! Check out all the jobs and post your resume.

Back to news