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FDA Accepts Supplemental New Drug Application for Jakafi® ruxolitinib and Priority Review Granted

August 20, 2014

By a News Reporter-Staff News Editor at Biotech Week -- Incyte Corporation (Nasdaq:INCY) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for ruxolitinib as a potential treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. The sNDA includes results from the RESPONSE Phase III trial, which were recently presented at the 2014 American Society of Clinical Oncology (ASCO) annual meeting. RESPONSE was conducted under a Special Protocol Assessment (SPA) from the FDA (see also Incyte Corporation).

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

"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," stated Richard Levy, M.D., Executive Vice President and Chief Drug Development and Medical Officer of Incyte. "We look forward to working with the FDA to complete its review of this application".

PV is a form of blood cancer leading to the overproduction of normal red blood cells, white blood cells and platelets. Patients with uncontrolled PV have an increased risk of cardiovascular complications such as stroke, pulmonary embolism, deep vein thrombosis and heart attack.

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 demonstrate efficacy in a Phase III trial in patients with polycythemia vera and, if approved, would be the first JAK1/JAK2 inhibitor made available to patients with polycythemia vera in the U.S. About Polycythemia Vera Polycythemia vera (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.1-4 Erythrocytosis (elevated red blood cell mass) is the most prominent clinical manifestation of PV, distinguishing it from other MPNs.5 PV may occur at any age but often presents later in life, with a median age at diagnosis of 60 years.6,7 Approximately 100,000 patients in the United States are living with PV8 and approximately 25 percent of patients with PV develop resistance to or intolerance of hydroxyurea9,10 and are considered uncontrolled. About JakafiŽ (ruxolitinib) Jakafi is a prescription medicine approved by the U.S. Food and Drug Administration to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. Jakafi is marketed by Incyte in the United States and by Novartis as JakaviŽ (ruxolitinib) outside the United States. Important Safety Information Jakafi can cause serious side effects including: Low blood counts: Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you experience unusual bleeding, bruising, fatigue, shortness of breath, or a fever. Infection: You may be at risk for developing a serious infection while taking Jakafi. Tell your healthcare provider if you develop symptoms such as chills, nausea, vomiting, aches, weakness, fever, or painful skin rash or blisters. The most common side effects of Jakafi include dizziness and headache. These are not all the possible side effects of Jakafi. Ask your healthcare provider or pharmacist for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had liver or kidney problems, are on dialysis, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.

Keywords for this news article include: Therapy, Blood Cells, FDA Actions, Polycythemia Vera, Bone Marrow Diseases, Hematologic Diseases, Clinical Trials and Studies, Hemic and Lymphatic Diseases, Myeloproliferative Disorders, Government Agencies Offices and Entities.

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Source: Biotech Week

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