The U.S. Food and Drug Administration approved Incyte Corp.'s Jakafi as the first treatment for a complication of a stem cell transplant in patients at least 12 years old.
Jakafi, also known as ruxolitinib, was approved to treat acute graft versus host disease, or aGVHD, in patients who do not respond to steroid therapy. The condition occurs after stem cell transplants when the donated cells start an immune response and attack the transplant recipient's organs.
The approval of the drug was supported by data from a clinical trial, named REACH1, which evaluated Jakafi in combination with corticosteroids in patients with the disease.
Data from the study showed that 57% of 49 patients who did not respond to steroids saw a reduction in their disease, while 31% of these patients had no signs of the disease after 28 days.
The FDA gave Jakafi a priority review and previously granted the drug an orphan-drug designation and breakthrough-therapy designation for aGVHD.
Jakafi is already approved for myelofibrosis, a type of chronic leukemia, and polycythemia vera, which causes the bone marrow to produce too many red blood cells.