FDA approves Incyte and Syndax chronic graft-versus-host disease drug

The US 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), from US biotech Incyte Corp (Nasdaq: INCY) and Syndax Pharmaceuticals(Nasdaq: SNDX). This application was granted priority review.

“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 of Incyte, adding: “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.”

Incyte paid $117 million upfront in 2021 for worldwide rights to the antibodyand also made a $35-million equity investment in Syndax, which. stands to receive up to $450 million in Niktimvo-related milestones.