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Niktimvo FDA Approval History

FDA Approved: Yes (First approved August 14, 2024)
Brand name: Niktimvo
Generic name: axatilimab-csfr
Dosage form: Injection
Company: Incyte and Syndax Pharmaceuticals
Treatment for: Graft-versus-host disease

Niktimvo (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody used for the treatment of chronic graft-versus-host disease.

Development timeline for Niktimvo

DateArticle
Aug 14, 2024Approval FDA Approves Niktimvo (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD)
Dec 10, 2023Incyte and Syndax Present Additional Data from Positive AGAVE-201 Trial at ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses in Chronic Graft-Versus-Host Disease
Jul 24, 2023Positive Topline Results from the Pivotal AGAVE-201 Trial of Axatilimab in Chronic Graft-Versus-Host Disease

Further information

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