Incyte Announces EU Regulatory Milestone for Ruxolitinib

Incyte Corporation

announced today a European Union (EU) regulatory milestone from Novartis. The milestone includes a $40 million payment earned based on the recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for approval of ruxolitinib 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. A second payment of $60 million would be earned once Novartis achieves reimbursement and pricing approval in specific EU countries. Ruxolitinib was approved by the US Food and Drug Administration (FDA) in November 2011 and is the first and only JAK inhibitor to have received regulatory approval. Ruxolitinib is known as Jakafi™ (ruxolitinib) in the US and will be called Jakavi™ in Europe.