Incyte and partner Syndax Pharmaceuticals on Tuesday secured regulatory clearance to market a third-line chronic graft-versus-host disease treatment, or cGVHD.
The agency greenlit the duo’s axatilimab, a colony stimulating factor-1 receptor-blocking antibody that will be marketed as Niktimvo. The approval came 14 days ahead of the FDA’s decision deadline. The companies plan to launch the antibody during the fourth quarter of this year, Syndax recently said during a second-quarter update.
Incyte already markets a cGVHD treatment known as Jakafi. Novartis sells it in other markets as Jakavi. Before the end of this year, Incyte plans to test Niktimvo in combination with Jakafi for earlier lines of cGVHD treatment in a Phase 2 trial. It also plans to run a Phase 3 of Niktimvo in combination with steroids.
Wilmington, DE-based Incyte will lead the commercialization. It will comprise 70% of the sales effort, and Syndax will contribute the remainder, according to
