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  • New drug 'Niktimvo' for cGVHD receives ODD in Korea
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Apr 4, 2025 05:58am
Gained attention as a new treatment option for patients who progressed after prior treatments
The AGAVE-201 clinical trial showed Niktimvo's ORR improvement
'Niktimvo,' a new drug for the treatment of chronic graft-versus-host disease (cGVHD), has been designated as an orphan drug in South Korea.

The Ministry of Food and Drug Safety (MFDS) announced this on the notifications of Orphan Drug Designation (ODD).

Niktimvo (axatilimab)'s basis for ODD indication is for the treatment of 'adults and pediatric patients over 40 kg with chronic graft-versus-host disease (cGVHD) after failure of two or more systemic therapy.'

In August last year, Niktimvo secured the U.S. Food and Drug Administration (FDA) approval It is a cGVHD treatment jointly developed by Incyte Corporation and Syndax Pharmaceuticals, a company in Massachusetts specializing in developing anticancer agent
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