Incyte granted FDA priority review for ruxolitinib sNDA
Incyte announced that the FDA has accepted for Priority Review its supplemental New Drug Application, or sNDA, for ruxolitinib for the treatment of patients with acute graft-versus-host-disease who have had an inadequate response to corticosteroids. The FDA grants Priority Review to medicines that have the potential to provide significant improvements in the treatment of a serious disease. This designation shortens the FDA review period to six months compared to 10 months for Standard Review. The sNDA submission is based on data from the REACH1 study evaluating ruxolitinib in combination with corticosteroids in patients with acute GVHD who have had an inadequate response to corticosteroids. Topline results from this ongoing trial demonstrated an overall response rate of 55% at Day 28, the primary endpoint. In addition, the best overall response rate was 73%.