WASHINGTON (dpa-AFX) - Incyte (INCY) said that the U.S. Food and Drug
Administration has accepted for
Priority Review the Biologics License Application or BLA for axatilimab, an
anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease
(GVHD) after failure of at least two prior lines of systemic therapy.

The Prescription Drug User Fee Act (PDUFA) date for the FDA decision is August
28,
2024.

Axatilimab is being developed by Incyte and Syndax Pharmaceuticals (SNDX) as
part of an exclusive worldwide co-development and co-commercialization license
agreement. The FDA grants Priority Review designation to applications for
medicines that, if approved, would treat a serious condition and provide
significant improvements in the safety or effectiveness of the treatment.

Incyte's Axatilimab Receives FDA Priority Review for Chronic Graft-Versus-Host
Disease Treatment.

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