NDA Accepted for Filing for Ruxolitinib for Myelofibrosis
Incyte Corporation announced that the FDA has accepted for filing its New Drug Application (NDA) for ruxolitinib as a potential treatment for patients with myelofibrosis. The NDA includes results from two Phase 3 trials, COMFORT-I conducted by Incyte and COMFORT-II conducted by Novartis, under the Incyte-Novartis worldwide collaboration and license agreement. The FDA has granted Incyte's request for Priority Review and has a goal to complete the review within six months. If the application is approved, Incyte anticipates ruxolitinib could be available in the U.S. in the fourth quarter of 2011.
Ruxolitinib is an investigational Janus kinase (JAK) 1 and 2 inhibitor with potential use in hematological disorders in addition to myelofibrosis.
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