Priority Review underway for Jakafi in chronic GVHD

23 February 2021

The US regulator has accepted for Priority Review a submission to broaden the label for Jakafi (ruxolitinib), to include treatment of chronic graft-versus-host disease (GVHD).

Developed by USA-based Incyte (Nasdaq: INCY), Jakafi is a first-in-class JAK1/JAK2 inhibitor, currently approved for use in polycythemia vera and in myelofibrosis.

Jakafi has also already been approved by the US Food and Drug Administration, since 2019, for the treatment of steroid-refractory acute GVHD, based on the results of the pivotal REACH1 trial.

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