Incyte receives FDA approval for Jakafi to treat intermediate or high-risk MF

Incyte CorporationNov 17 2011

Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Jakafi™ (ruxolitinib) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. Patients with intermediate and high-risk MF represent 80 to 90 percent of MF patients. Jakafi (JAK-ah-fye) is the first and only product to be approved by the FDA for MF, and the first in a new class of drugs, known as JAK inhibitors, to be approved for any indication. Jakafi is an oral JAK1 and JAK2 inhibitor.

"The availability of Jakafi is a significant medical advancement for people living with myelofibrosis, a debilitating disease," stated Paul A. Friedman, M.D., President and Chief Executive Officer of Incyte. "This milestone marks a tremendous achievement for Incyte because a scientific discovery from our research laboratories has become the first JAK inhibitor to reach the market and provide a clinical benefit to patients."

MF is a progressive, potentially life-threatening blood cancer with limited treatment options. Patients with MF suffer a high disease burden characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms including fatigue, severe itching (pruritus), night sweats, bone pain, and early satiety (a feeling of fullness), leading to impaired quality of life. The enlarged spleen and debilitating symptoms of MF are linked to dysregulated signaling in the Janus kinase (JAK) pathway.

"Today's FDA approval of Jakafi has the potential to transform the way we treat myelofibrosis," said Srdan Verstovsek, M.D., Ph.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and the principal investigator of the COMFORT-I pivotal trial. "In this Phase III clinical trial, we observed significant reductions in spleen size and significant improvements in symptoms. Importantly, these benefits were achieved early on, most within a month, and tended to be durable during treatment. In contrast, most of the patients who received placebo saw their spleens increase and their symptoms worsen."

"We are very excited about the first FDA approval of a treatment for MF. Not only is this a new therapy, but it brings additional education, awareness and attention to a profoundly debilitating disease," stated Robert Rosen, President of MPN Research Foundation.