FDA Grants Priority Review to Ruxolitinib for GVHD

October 26, 2018 – The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for ruxolitinib for the treatment of patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids, according to Incyte, the manufacturer of the JAK1/JAK2 inhibitor. The sNDA is based on results from the pivotal phase II REACH1 trial, in which ruxolitinib combined with corticosteroids induced an overall … (leggi tutto)