FDA grants Priority Review to Incyte's Jakafi for acute GvHD

Incyte Corp. (NASDAQ:INCY) said FDA accepted and granted Priority Review to an sNDA seeking approval for Jakafi ruxolitinib to treat acute graft-versus-host disease (GvHD) in patients with inadequate response to corticosteroids. The PDUFA date was not disclosed.

Jakafi plus corticosteroids met the primary endpoint in the Phase II REACH1 trial in the indication (see "Incyte's Jakafi Meets in Phase II for Steroid-Refractory GvHD"). ...