Incyte Corporation announced promising results for its blockbuster drug Jakafai in treating a condition coming out of bloodstem cell transplants.
Incyte is based near Wilmington. Jakafi has emerged as a $1 billion sales drug for Incyte.
The Phase 2, REACH1 study evaluated the drug in combination with corticosteroids as a treatment for patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids.
GVHD is a condition that can occur after an allogeneic transplant (the transfer of genetically dissimilar blood stem cells) where the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body, leading to significant mortality in transplant recipients.
There are two forms of the condition, which can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver. Acute GVHD typically occurs within the first 100 days following an allogeneic transplant. With acute GVHD, up to 40 percent of patients have severe disease, resulting in a 12-month survival of 50 percent or less.
“The updated results of the REACH1 study being presented at ASH further illustrate the potential of JAK inhibition as a therapeutic option in GVHD, and specifically reinforce the durability of responses seen in acute GVHD patients treated with ruxolitinib,” said Steven Stein, M.D., chief medical officer, Incyte. “We are currently working with the FDA to facilitate the expedited review of the sNDA for ruxolitinib in steroid refractory acute GVHD, and, if approved, we believe ruxolitinib will provide an innovative treatment option for U.S. patients with this deadly disease.”
Data from the REACH1 study supported the submission of a supplemental New Drug Application (sNDA) by Incyte which was accepted for Priority Review by the U.S. Food and Drug Administration and assigned a Prescription Drug User Fee Act (PDUFA) date of February 24, 2019. The FDA grants Priority Review to medicines that have the potential to provide significant improvements in the treatment of a serious disease.