Incyte: FDA Grants Priority Review For Ruxolitinib

(RTTNews) - Incyte Corp. (INCY) said Thursday that the U.S. Food and Drug Administration has accepted for Priority Review its supplemental New Drug Application or sNDA for ruxolitinib, or Jakafi, for the treatment of patients with acute graft-versus-host-disease (GVHD) 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.

Incyte noted that 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 percent at Day 28, the primary endpoint. In addition, the best overall response rate was 73 percent.

GVHD is a condition that can occur after an allogeneic transplant (the transfer of genetically dissimilar blood stem cells) and is a significant cause of morbidity and mortality in transplant recipients.

In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign and attack the body. There are two forms of GVHD, acute and chronic, which can affect multiple organ systems including the skin, gastrointestinal tract and liver.