Novartis’ Jakavi® (ruxolitinib, INC424) has become the first drug to be approved by the EC for treating myelofibrosis. Regulatory clearance in Europe covers use of the JAK1/2 inhibitor for treating disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
Novartis’ holds a license from Incyte to develop and commercialize ruxolitinib in all global territories outside the U.S., for all hematology-oncology indications. Incyte retains U.S. rights to the drug (trade-named Jakafi®), which was approved by FDA in November 2011 for treating intermediate or high-risk myelofibrosis, including primary myelofibrfosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.
Approval of Jakavi in Europe was based on a clinical program including two pivotal Phase III trials, Comfort-1 and Comfort-II, which demonstrated that the drug led to statistically significant reductions in spleen volume and myelofibrosis symptoms from baseline when compared with either placebo or best available therapy.
“This approval marks a significant milestone in addressing unmet treatment needs for patients in the European Union,” remarks Hervé Hoppenot, president, Novartis Oncology. “We are committed to the development of innovative treatments for orphan diseases, and are furthering research to assess the potential of targeted Jakavi therapy for other malignancies associated with a dysregulated JAK pathway.”