WILMINGTON — Incyte Corporation, based in Wilmington, has announced the first patient has been treated in the REACH-1 pivotal Phase 2 trial evaluating its ruxolitinib drug, trademarked Jakafi. The drug was used in combination with corticosteroids for the treatment of steroid-refractory acute graft-versus-host disease.
“We are very pleased to have the first patient treated in the pivotal trial program for ruxolitinib in GVHD, a severe and often life-threatening condition for which there are currently no approved treatments,” said Dr. Steven Stein, the company’s chief medical officer. “We look forward to building on the clinical evidence to-date for ruxolitinib and working with regulators to help address the urgent needs of these patients.”
Graft-versus-host disease is a condition that might occur after the transfer of genetically dissimilar blood stem cells. 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. GVHD is a significant cause of morbidity and mortality in transplant recipients. The U.S. Food and Drug Administration granted ruxolitinib breakthrough therapy designation for the treatment of acute GVHD, a designation that allows expedited development and review of drugs for serious or life-threatening conditions.
It also granted orphan drug designation for the treatment of GVHD, granted to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.