NVS - Novartis Incyte's Jakavi gets approval in EU to treat graft-versus-host disease

The European Commission (EC) approved Novartis (NYSE:NVS) and Incyte's (INCY) Jakavi (ruxolitinib) to treat patients aged 12 years and older with acute or chronic graft-versus-host disease (GVHD) who have inadequate response to corticosteroids or other systemic therapies. "Jakavi, with this new indication in GvHD, will help to redefine treatment for patients who do not respond to first-line care," said France Tschudin, Novartis president of Innovative Medicines International and chief commercial officer. Ruxolitinib is marketed by Novartis as Jakavi in Europe and as Jakafi by Incyte in the U.S. The EC approval follows positive opinion by a panel of the European Medicines Agency, in March. The approval was backed by data from phase 3 studies, REACH2 and REACH3. In the EU, Jakavi is already approved to treat polycythemia vera and primary myelofibrosis in certain patients. The drug is already approved in the U.S. for certain patients with GVHD. GVHD is a life-threatening complication of stem

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Novartis, Incyte's Jakavi gets approval in EU to treat graft-versus-host disease