European Commission approval of Jakavi as the first post-steroid treatment for acute and chronic graft-versus-host disease.
Incyte has announced the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GVHD who have inadequate response to corticosteroids or other systemic therapies.
Ruxolitinib is marketed as Jakavi by Novartis in Europe and as Jakafi by Incyte in the United States.
Jakavi (ruxolitinib) is the first JAK1/2 inhibitor available for patients in Europe who previously had no approved therapies for the treatment of steroid-refractory graft-versus-host disease (GVHD). In clinical trials, Jakavi demonstrated superiority versus best available therapy in patients with steroid-refractory/dependent acute and chronic GVHD, with overall response rates of 62% vs. 39%, and 50% vs. 26% respectively. GVHD is a common and potentially life-threatening complication that arises in approximately half of patients following allogeneic stem cell transplants.
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