Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD.
Breakthrough Therapy Designation is designed to expedite the development and review of drugs for serious or life-threatening conditions and to help ensure people have access to them through FDA approval as soon as possible. The criteria for awarding Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have clinically significant improvement over available therapy.
“Receiving Breakthrough Therapy Designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to-date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “We are committed to working closely with the FDA in an effort to bring ruxolitinib to patients with GVHD as soon as possible.”
In March 2016, Incyte and Lilly agreed to amend their License, Development and Commercialization Agreement to enable Incyte to independently develop and commercialize ruxolitinib for GVHD. In April 2016, Incyte and Novartis also agreed to amend their Collaboration and License Agreement, granting Novartis the rights to research, develop and commercialize ruxolitinib for GVHD outside the U.S.
