Incyte nears the finish line for first FDA approved treatment for myelofibrosis
During ASCO's annual meeting Incyte announced that it has submitted a New Drug Application (NDA) for Ruxolitinib to the US Food and Drug Administration. They have requested a Priority Review of the application. Ruxolitinib is the first JAK1/JAK2 inhibitor to near commercialization and is now being investigated in other hematology conditions. It is the first JAK inhibitor to be submitted to the FDA for the treatment of MF.
For MPN patients who have waited for treatments targeted to their disease, this is very good news. 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.
Only six years ago, the JAK2 gene mutation was discovered. The MPN Research Foundation immediately responded to this news and believe our research initiatives and patient education programs have had a direct impact on the course of drug development today. The MPN Research Foundation played a key role in supporting the discovery work for JAK2 and are encouraged by the rapid progress and growing interest in this underserved therapeutic area. The Foundation's preclinical testing of JAK inhibitors and the determination to continue to fund new and innovative research kindles the hope that new treatments for all MPN patients is on the horizon.
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