Incyte (INCY) and Syndax Pharmaceuticals (SNDX) have announced that the U.S. Food and Drug Administration has granted approval for Niktimvo (axatilimab-csfr) available in vial sizes of 9 mg and 22 mg. The companies anticipate that the product will be ready for order in the U.S. by early February.
Niktimvo has been approved for use in treating chronic graft-versus-host disease (GVHD) in both adult and pediatric patients who weigh a minimum of 40 kg (88.2 lbs). This approval follows the failure of at least two previous systemic therapy lines.
Niktimvo is distinguished as the first and only FDA-approved prescription medication specifically targeting the CSF-1R to alleviate the underlying causes of inflammation and fibrosis in chronic GVHD.
For adults and pediatric patients weighing at least 40 kg, the recommended dosage of Niktimvo is 0.3 mg/kg, with a cap of 35 mg, administered as an intravenous infusion over a 30-minute period every two weeks. Healthcare providers will have access to Niktimvo through a network of specialty distributors, with both the 9 mg and 22 mg vial sizes available, ensuring flexible dosing for patients, as stated by the companies.
