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FDA Grants Priority Review for Ruxolitinib (Jakafi) for Treatment of Polycythemia Vera

Approval decision set for December

The FDA has accepted for filing a supplemental new drug application (sNDA) for ruxolitinib (Jakafi, Incyte Corp.) as a potential treatment for patients with polycythemia vera (PV) who have shown an inadequate response to or are intolerant of hydroxyurea.

The sNDA includes results from the phase III RESPONSE trial, which were recently presented at the 2014 American Society of Clinical Oncology (ASCO) annual meeting.

The Prescription Drug User Fee Act (PDUFA) date for ruxolitinib was set for December 5, 2014.

Ruxolitinib is the first FDA-approved treatment for patients with intermediate- or high-risk myelofibrosis (MF), including primary MF, post–PV MF, and post–essential thrombocythemia MF. Ruxolitinib is also the first JAK1/JAK2 inhibitor to demonstrate efficacy in a phase III study of patients with PV and, if approved, would be the first JAK1/JAK2 inhibitor made available to patients with this disorder in the U.S.

PV is a myeloproliferative neoplasm (MPN) characterized by an overproduction of normal red blood cells, white blood cells, and platelets that leads to an increased risk of thrombosis. Erythrocytosis is the most prominent clinical manifestation of PV, distinguishing it from other MPNs. Patients with uncontrolled PV have an increased risk of cardiovascular complications, such as stroke, pulmonary embolism, deep vein thrombosis, and heart attack.

PV may occur at any age but often presents later in life, with a median age of 60 years at diagnosis. Approximately 100,000 patients in the U.S. have PV, and approximately 25% of these patients develop resistance to or intolerance of hydroxyurea and are considered uncontrolled.

Source: Incyte Corporation; August 5, 2014.

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