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news.The US Food and Drug Administration (FDA) has accepted for filing the supplemental new drug application (sNDA) for US-based biopharmaceutical firm Incyte's Jakafi (ruxolitinib) as a potential treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.
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Polycythemia vera is a form of blood cancer that leads to the overproduction of normal red blood cells, white blood cells and platelets.
The filing of the sNDA is based on results from the RESPONSE Phase III trial, which was conducted under a Special Protocol Assessment (SPA) from the FDA.
The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ruxolitinib is set for 5 December 2014.
Incyte executive vice-president and chief drug development and medical officer Richard Levy said: "We are pleased to have received the acceptance of our sNDA filing by the FDA, and we believe that the submission contains a robust data set.
"We look forward to working with the FDA to complete its review of this application."
People with uncontrolled PV have an increased risk of cardiovascular complications, including stroke, pulmonary embolism, deep vein thrombosis and heart attack.
The company said that Jakafi is the first and only FDA-approved treatment for patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.
Ruxolitinib is also the first JAK1/JAK2 inhibitor to show efficacy in a Phase III trial in patients with polycythemia vera and, if approved, it would be the first JAK1/JAK2 inhibitor made available to patients with polycythemia vera in the US.