US FDA grants priority review as it accepts Incyte ruxolitinib NDA for myelofibrosis

The US Food and Drug Administration has accepted for filing the New Drug Application (NDA) for drug developer Incyte’s (Nasdaq: INCY) lead investigational compound, ruxolitinib (INCB18424/INC424), as a potential treatment for patients with myelofibrosis (MF), a form of blood cancer.

The drug is partnered with Swiss drug major Novartis (NOVN: VX), which acquired commercialization rights for the compound in return for an upfront payment of $150 million (The Pharma Letter November 26, 2009).

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 drug has received orphan drug status from both the FDA and European Medicines Agency. The agency 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.