WILMINGTON, Del. - Incyte (NASDAQ:INCY) Corporation (NASDAQ:INCY) has received Priority Review designation from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for axatilimab. This investigational treatment is aimed at patients with chronic graft-versus-host disease (GVHD) who have not responded to at least two previous systemic therapies. The FDA's decision date is set for August 28, 2024.
The Priority Review status is granted to drugs that could potentially provide significant improvements in the treatment of serious conditions. Axatilimab, an anti-CSF-1R antibody, has shown positive outcomes in the AGAVE-201 clinical trial, demonstrating meaningful clinical results and a manageable safety profile.
Chronic GVHD is a severe and potentially life-threatening condition that can develop in approximately 40% of allogeneic hematopoietic stem cell transplantation recipients. It is characterized by the immune response of donor-derived cells against recipient tissues, often leading to long-lasting complications affecting multiple organ systems.
Axatilimab operates by targeting the colony stimulating factor-1 receptor (CSF-1R), which is believed to play a critical role in the survival and function of monocytes and macrophages, cells implicated in the fibrotic process of diseases like chronic GVHD.
Incyte and Syndax Pharmaceuticals (NASDAQ:SNDX) are collaborating under an exclusive worldwide co-development and co-commercialization license agreement to advance axatilimab. The AGAVE-201 trial, which supported the BLA, was a global Phase 2 study assessing axatilimab's efficacy, safety, and tolerability in patients with chronic GVHD who had exhausted other treatment options.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.