Press release
Incyte and Syndax Announce U.S. FDA Approval of Niktimvo™ (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD)
Niktimvo™ (axatilimab-csfr) is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD Pivotal data
About this update from Incyte Corporation
[{"type":"text","content":"\n\nNiktimvo™ (axatilimab-csfr) is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD\n\n\n\nPivotal data from the AGAVE-201 study supporting the approval show treatment with Niktimvo resulted in durable responses across all organs studied and patient subgroups\n\n\n\nSyndax conference call and webcast scheduled for today at 6:00 p.m. ET\n\n\n\n WILMINGTON, Del. & WALTHAM, Mass.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr), 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 in adult and pediatric patients weighing at least 40 kg (88.2 lbs.).\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240814470216/en/\n“With the approval of Niktimvo, patients with chronic GVHD whose disease has progressed after prior therapies, now have a new treatment option with a novel mechanism of action to help address the serious and devastating complications associated with this disease,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “Niktimvo is Incyte’s second approved treatment for chronic GVHD, underscoring our continued commitment to advancing the development of new medicines on behalf of patients with this disease and the medical community.”\n\n\nChronic GVHD is a serious condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient’s organs. Chronic GVHD is a leading cause of significant morbidity and mortality after an allogeneic stem cell transplant and is estimated to develop in approximately 42% of transplant recipients, affecting approximately 17,000 patients in the U.S.1 Of those patients who develop chronic GVHD, nearly 50% require at least three lines of treatment, emphasizing the need for additional effective treatment options.2\n\n\n“The approval of Niktimvo represents a significant treatment advancement for patients with chronic GVHD who have failed at least two lines of previous therapy,” said Michael A. Metzger, Chief Executive Of...