Incyte Corp., Wilmington, announced positive results from its Phase 2 REACH1 trial evaluating its blockbuster drug Jakafi used in combination with corticosteroids for patients with a condition related to stem cell transplant rejections.
Jakafi is used in the treatment of blood conditions.
Based on the data Incyte plans to file a Supplemental New Drug Application for the approval of ruxolitinib with the U.S. Food and Drug Administration (FDA) during the third quarter of 2018.
“The results of the REACH1 study demonstrate the potential of ruxolitinib to meaningfully improve the outcomes of allogeneic transplant patients who develop steroid-refractory acute GVHD and further underscore the promise of JAK inhibition to advance the treatment of this potentially devastating condition,” said Steven Stein, M.D., chief medical officer, Incyte.
GVHD is a condition that can occur after an allogeneic transplant (the transfer of genetically dissimilar blood stem cells).
In GVHD, 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 (digestive) tract and liver.
The condition has increased along with the use of transplants and is associated with first-year mortality ranging from 25 to 75 percent, according to Madan Jagasia of Vanderbilt University Medical Center. “Despite available therapies for acute GVHD, patients do not always respond, underscoring the need for new and innovative treatment options for these patients.”
The FDA previously granted ruxolitinib Breakthrough Therapy Designation for the treatment of steroid-refractory acute GVHD, as well as Orphan Drug Designation.
