US biopharmaceutical companies Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) announced on Wednesday that they have received approval from the US Food and Drug Administration (FDA) for Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes.

The product will be available to order in the United States in early February.

Niktimvo is approved for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and paediatric patients weighing at least 40kg (88.2 lbs). Niktimvo is the first and only FDA-approved prescription treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis.

Herve Hoppenot, Incyte CEO, said: "We are thrilled to build on our strong commitment to the GVHD community with the US launch of Niktimvo, a first-in-class therapeutic agent that has demonstrated remarkable responses in patients with chronic GVHD whose response was suboptimal after at least two prior lines of systemic therapy. Our deep understanding of chronic GVHD and our connections in the clinical community will support a successful launch, in partnership with Syndax, of this important medicine for patients."