Incyte Corp. announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application use of Jakafi for the treatment of patients with acute graft-versus-host disease.
Jakafi is Delaware-based Incyte’s top drug in total revenues. The drug is primarily used the treating a type of drug cancer.
The study included patients who have had an inadequate response to corticosteroids.
The FDA extended the action date to allow time to review additional data submitted by Incyte in response to the FDA’s information requests.
“We remain confident in the data supporting our sNDA submission and look forward to continued dialogue with the FDA throughout the review process,” said Steven Stein, M.D., chief medical officer, Incyte. “We are committed to bringing ruxolitinib forward as a treatment option for patients with acute GVHD.”
The FDA has granted both the Priority Review and Breakthrough Therapy Designation. The FDA grants Priority Review to medicines that have the potential to provide significant improvements in the treatment of a serious disease.
Additionally, the FDA granted Jakafi Orphan Drug Designation for the treatment of GVHD, a designation granted to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.