axatilimab-csfr

FDA Drug Profile — NIKTIMVO

Drug Details

Generic Name
axatilimab-csfr
Brand Names
NIKTIMVO
Application Number
BLA761411
Sponsor
Incyte Corporation
NDC Codes
3
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
AXATILIMAB

Indications and Usage

1 INDICATIONS AND USAGE NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. NIKTIMVO is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. ( 1 )