Incyte Corporation (INCY) announced its strategic collaborator, Novartis, received approval from the European Commission for Jakavi, or INC424, ruxolitinib, an oral JAK 1 and JAK 2 inhibitor discovered by Incyte, for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, or chronic idiopathic myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
Myelofibrosis is a life-threatening blood cancer associated with progressive, debilitating symptoms that can severely impact quality of life and shorten survival. Novartis said the European Commission's decision was based on positive findings from the COMFORT, or COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy, clinical trial program.
Incyte entered into a worldwide collaboration and license agreement with Novartis in 2009. Novartis received exclusive rights to the development and potential commercialization of ruxolitinib in all hematology-oncology indications outside of the United States. Incyte retained exclusive rights for the development and commercialization of ruxolitinib in the United States, and received approval from the U.S. Food and Drug Administration in November 2011 for ruxolitinib, marketed in the United States under the brand name Jakafi.
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