EU Commission approves Jakavi (Novartis) for Myelofibrosis

Novartis received approval from the European Commission for Jakavi (INC424, ruxolitinib), a JAK 1 and JAK 2 inhibitor for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as Chronic Idiopathic Myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. The European Commission's decision was based on positive findings from the COMFORT (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy) clinical trial program. "The approval of Jakavi by the European Commission brings an urgently needed new treatment option with the potential to make a real difference in patients' lives," said Dr. Claire Harrison, MD, Guy's and St. Thomas' NHS Foundation Trust, Guy's Hospital, London. "By targeting the dysregulated JAK pathway, Jakavi delivers a rapid and durable benefit that has the potential to become a new standard of care."