Incyte's Jakafi a Breakthrough Therapy for GVHD

• The FDA designates Incyte's (NASDAQ:INCY) Jakafi (ruxolitinib) a Breakthrough Therapy for the treatment of acute graft-versus-host disease (GVHD), a condition where the donated tissue, bone marrow or peripheral blood stem cells, view the recipient's body as foreign and attack the body. It is a significant cause of morbidity and mortality in transplant patients. There are no currently approved treatments for the disorder.
• Breakthrough Therapy status allows for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
• Jakafi is a JAK1/JAK2 inhibitor cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis. Novartis (NVS) owns ex-U.S. rights to the product which now includes the GVHD indication. Incyte owns the U.S. rights.