Incyte announced Friday that the FDA approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in patients aged 12 years and older. "For the first time, patients with steroid-refractory acute GVHD...have an FDA-approved treatment for this serious disease," stated CEO Hervé Hoppenot, adding that the approval also marks the third indication for the JAK1/JAK2 inhibitor in the US.
The FDA decision was supported by data from the Phase II REACH1 trial evaluating Jakafi in combination with corticosteroids in 71 patients with steroid-refractory grade II-IV acute GVHD. Top-line results unveiled last June showed that the study had achieved its primary endpoint, with an overall response rate of 55 percent after 28 days.
The agency assessed Jakafi under a priority review, and has also granted it breakthrough therapy and orphan drug status for the treatment of steroid-refractory GVHD. Jakafi is also approved in the US for use in certain patients with polycythaemia vera and intermediate- or high-risk myelofibrosis.
Incyte gained rights to Jakafi for GVHD from Eli Lilly under the terms of a 2016 agreement, which also saw Incyte grant Novartis exclusive rights to the JAK1/JAK2 inhibitor in GVHD outside the US. Incyte recorded sales of about $376 million for the treatment in the first quarter.
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