Incyte and Syndax to scale Niktimvo production after FDA approvalIncyte and Syndax to scale Niktimvo production after FDA approval

Incyte and Syndax Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Niktimvo (axatilimab) in 9 mg and 22 mg vial sizes. Niktimvo is approved to treat GVHD in both adults and children in cases when two previous lines of treatment have failed.

According to Incyte, the product is codeveloped with Syndax as part of a worldwide co-development and co-commercialization license agreement, with Incyte retaining exclusive commercialization rights outside the US.

BioProcess Insider spoke with a representative from Incyte to learn more about how the company is preparing for increased manufacturing needs ahead of February 2025, when the product will be available for purchase in the US. According to the spokesperson, Niktimvo is manufactured both at Incyte’s own Yverdon, Switzerland BioPlant and through partnerships with a combination of contract manufacturing organizations (CMOs).

The representative said that Incyte estimated a manufacturing scale in line with increased demand, and the company is prepared to adjust its output. “For the drug substance (DS),” the spokesperson said, “the scale is fixed.  In order to satisfy increasing demand, the number of batches will be increased.”

The spokesperson said that Nimtimvo is currently being produced in 2000-L bioreactors. “Following the removal of the cells, the product is purified using several different chromatography resins and filtration systems. Purification equipment is sized based on the bioreactor volume and the productivity. After purification, the DS is aseptically filled into bags and then frozen.”

The batch scale is flexible for the drug product (DP) over a validated range between about 10,000–50,000 vials per batch, which enables more flexibility. “To manufacture the DP, several DS bags are thawed, pooled, and filtered. An aseptic filling machine is used to fill and seal the glass vials with the correct dose.”

With news of the approval, Hervé Hoppenot, CEO of Incyte 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."