Press release
Incyte Announces Positive CHMP Opinion for Ruxolitinib (Jakavi®) for the Treatment of Acute and Chronic Graft-Versus-Host Disease
The positive opinion from the CHMP is based on data from the Phase 3 REACH2 and REACH3 trials, which demonstrated that ruxolitinib (Jakavi®) improved
About this update from Incyte Corporation
[{"type":"text","content":"\n\nThe positive opinion from the CHMP is based on data from the Phase 3 REACH2 and REACH3 trials, which demonstrated that ruxolitinib (Jakavi®) improved response rates and failure-free survival compared to best available therapy, which provides a promising opportunity for patients living with graft-versus-host disease (GvHD)1,2\n\n\nGraft-versus-host disease (GVHD) is a life-threatening complication of stem cell transplants, with no established standard of care in Europe for patients who do not adequately respond to first-line steroid treatment3,4\n\n\nNearly half of patients experience acute or chronic GVHD following allogeneic transplants 3,4\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of ruxolitinib (Jakavi®) for the treatment of patients aged 12 years and older with acute graft-versus-host disease or chronic graft-versus-host disease (GVHD) and who have inadequate response to corticosteroids or other systemic therapies. If approved, ruxolitinib will be the first JAK1/2 inhibitor available for patients with GVHD in Europe.4 Ruxolitinib is marketed as Jakavi by Novartis in Europe and as Jakafi® by Incyte in the U.S.\n\n“We are pleased that the CHMP has recommended approval of ruxolitinib for the treatment of acute or chronic GVHD in Europe,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. “With this positive opinion, patients living with these life-threatening complications who do not respond to first-line steroids therapies are one step closer to having a new potential standard of care.”\n\nThe CHMP positive opinion was based on data from the Phase 3 REACH2 and REACH3 clinical studies, in which ruxolitinib demonstrated superiority versus best available therapy (BAT) in patients with steroid-refractory and steroid-dependent acute and chronic GVHD, respectively.\n\nResults from the REACH2 trial showed an overall response rate (ORR) at Day 28 was superior in the ruxolitinib arm at 62.3% vs. 39.4% in the BAT arm (odds ratio [OR], 2.64; p","length":2955,"tagName":"div"}]