FDA Grants Breakthrough Therapy Designation for Incyte’s Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease

FDA Updates

Wilmington-based Incyte Corporation announced that the U.S. FDA has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD.

Graft-versus-host disease (GVHD) is a condition that might occur after an allogeneic transplant (the transfer of genetically dissimilar stem cells or tissue). 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 skin, gastrointestinal (digestive) tract, and liver are the most commonly affected organs in patients with GVHD.

In March 2016, Incyte and Lilly agreed to amend their License, Development and Commercialization Agreement to enable Incyte to independently develop and commercialize ruxolitinib for GVHD. In April 2016, Incyte and Novartis also agreed to amend their Collaboration and License Agreement, granting Novartis the rights to research, develop and commercialize ruxolitinib for GVHD outside the U.S.




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