INCY - Novartis Incyte Jakavi gets EMA panel nod for expanded use in graft-versus-host disease

A committee of the European Medicines Agency (EMA) recommended the approval for expanded use of Incyte (NASDAQ:INCY) and Novartis' Jakavi (ruxolitinib) to treat patients aged 12 years and older with acute graft-versus-host disease or chronic graft-versus-host disease (GVHD) who have inadequate response to corticosteroids or other systemic therapies. Ruxolitinib is marketed by Novartis as Jakavi in Europe and as Jakafi by Incyte in the U.S. The positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) was backed by data from phase 3 REACH2 and REACH3 studies. In EU, Jakavi is already approved to treat certain patients with primary myelofibrosis and certain adult patients with polycythaemia vera. The drug is already approved in the U.S. for certain patients with GVHD. GVHD is a life-threatening complication of stem cell transplants and occurs when the donor's immune system's white blood cells attack the recipient's cells.

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Novartis, Incyte Jakavi gets EMA panel nod for expanded use in graft-versus-host disease