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FDA Grants GVHD Treatment Priority Review

May 9, 2024

June 2024

The U.S. Food and Drug Administration (FDA) granted axatilimab priority review for the treatment of chronic graft-versus-host disease (GVHD) after at least two prior lines of systemic therapy have failed.

Axatilimab is a monoclonal antibody that works by targeting colony stimulating factor-1 receptor, a cell surface protein which may affect the survival and function of monocytes and macrophages.

Priority review was granted based on data from a global phase II trial dubbed AGAVE-201. The trial evaluated the treatment’s efficacy, safety, and tolerability in adult and pediatric patients with relapsed or refractory chronic GVHD.

“Despite recent advancements in the treatment of patients with chronic GVHD, there remains a significant unmet need for patients who progressed on earlier lines of therapy,” said Hervé Hoppenot, chief executive officer of Incyte. “Axatilimab’s novel mechanism offers a differentiated treatment approach which may help patients suffering from this devastating disease. We look forward to working closely with the FDA and our partners at Syndax on the review of our application for axatilimab for this indication.”

The Prescription Drug User Fee Act date is set for August 28, 2024.

Source: Business Wire, February 27, 2024.

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