24 May 2019 - Jakafi is the first and only FDA approved treatment for patientswith steroid-refractory acute graft-versus-host disease.
Incyte Corporation today announced that the U.S. FDA has approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute GVHD in adult and paediatric patients 12 years and older. Jakafi is the first and only FDA approved treatment for this indication.
The approval was based on data from REACH1, an open-label, single-arm, multicenter study of Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD.