Incyte and Syndax Secure FDA Approval for Niktimvo, a Breakthrough Treatment for Chronic Graft-Versus-Host Disease

FDA Approval:
Incyte and Syndax have received FDA approval for Niktimvo (axatilimab-csfr) to treat chronic graft-versus-host disease (GVHD) in patients who have failed at least two prior lines of systemic therapy.

Mechanism of Action:
Niktimvo is an anti-CSF-1R antibody, offering a novel mechanism of action to address the serious complications associated with GVHD.

Patient Eligibility:
The drug is approved for adult and pediatric patients weighing at least 40 kg (88.2 lbs) who have chronic GVHD after an allogeneic stem cell transplant.

Commercialization:
Incyte and Syndax will co-commercialize Niktimvo in the U.S., while Incyte holds exclusive commercialization rights outside the U.S..

Launch Plans:
The companies plan to launch Niktimvo in the U.S. by early Q1 2025, following the approval of additional vial sizes to reduce product waste.

Clinical Need:
Chronic GVHD is a significant cause of morbidity and mortality post-transplant, affecting approximately 42% of transplant recipients, with nearly 50% requiring at least three lines of treatment.

Priority Review:
The FDA granted Niktimvo Priority Review, indicating it provides significant improvements in safety or effectiveness for a serious condition.