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news.Incyte has received the US Food and Drug Administration (FDA) acceptance to submit the new drug application (NDA) for ruxolitinib (INCB18424/INC424) to treat myelofibrosis (MF) patients.
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Incyte has also received priority review status for ruxolitinib NDA, which the FDA aims to complete within six months.
The NDA submission is supported by the results from two Phase III Comfort-I and Comfort-II trials.
Ruxolitinib, Incyte’s lead JAK1 and JAK2 inhibitor, entered clinical testing in May 2007 and has shown clinical activity in a number of hematologic conditions.