Incyte Corporation (Nasdaq:INCY) announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Incyte's lead investigational compound, ruxolitinib (INCB18424/INC424), as a potential treatment for patients with myelofibrosis (MF). MF is a potentially life-threatening blood cancer with limited treatment options and no FDA-approved medicines. The FDA also has granted Incyte's request for Priority Review, which is given to investigational drugs that may offer either a major advance in treatment or provide a treatment where no adequate therapy exists. The FDA has a goal to complete the Priority Review within six months. Therefore, if the application is approved, Incyte anticipates that ruxolitinib could be available for US patients with MF in the fourth quarter of 2011.
The NDA includes results from two Phase III trials, COMFORT-I conducted by Incyte and COMFORT-II conducted by Novartis, under the Incyte-Novartis worldwide collaboration and license agreement. Results from both studies were recently presented at the 2011 American Society of Clinical Oncology annual meeting and the 16th Congress of the European Hematology Association.
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