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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