Incyte Corporation (Nasdaq:INCY) announced today that it has submitted a New Drug Application (NDA) for its lead investigational compound, ruxolitinib (INCB18424), to the US Food and Drug Administration (FDA). Incyte is seeking US marketing approval of ruxolitinib for the treatment of myelofibrosis (MF), a potentially life-threatening blood cancer for which there are currently no approved therapies in the US. The Company has requested a Priority Review of the application.
Incyte obtained a Special Protocol Assessment agreement from the FDA for the pivotal Phase III registration trial, COMFORT-I. The NDA includes results from both COMFORT-I and COMFORT-II, a second Phase III trial conducted by Novartis in Europe under the Incyte-Novartis worldwide collaboration and license agreement for ruxolitinib. Data from both studies are being presented today at the 2011 American Society of Clinical Oncology (ASCO) annual meeting.
Ruxolitinib was granted Fast Track designation by the FDA in October 2009. The Fast Track program is intended to facilitate the development and expedite the review of drug candidates that demonstrate the potential to address unmet medical needs for serious, life-threatening conditions.
Ruxolitinib, the lead JAK1 and JAK2 inhibitor discovered by Incyte, entered Phase I clinical testing in May 2007 and is being investigated in a number of hematology conditions. Ruxolitinib is the first JAK inhibitor to be submitted to the FDA for the treatment of MF.
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