US Food and Drug Administration approval of Incyte Corporation and Syndax Pharmaceuticals, Inc.’s Niktimvo (axatilimab-csfr) in chronic graft-versus-host disease (GVHD) sets the stage for competition with Sanofi’s Rezurock (belumosudil). It also rockets Syndax into the commercial stage as a company, with approval expected for revumenib in acute leukemia drug early in the fourth quarter, and it gives Incyte another product in the chronic GVHD space beyond its JAK inhibitor Jakafi (ruxolitinib), which will lose market exclusivity in four years.
Syndax Achieves Commercial Status As Incyte-Partnered GVHD Drug Gets FDA Nod
US FDA approval of Niktimvo for third-line chronic GVHD, a competitor to Sanofi’s Rezurock, came less than two months ahead of anticipated approval of Syndax’s leukemia drug revumenib.
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