Skip to main content
¿Necesita servicios de traducción?
Comuníquese con nuestra mesa de ayuda 24/7/365 al 877-635-9545.

New Gene Therapy Approval

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix, a gene therapy for treatment of adults with hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. Although hemophilia B is a rare condition, intravenous infusions to treat hemophilia B range from $550,000-$750,000 annually. Hemgenix is administered as a single dose intravenous infusion. Hemgenix will cost approximately $3.5 million, which will make it the most expensive medicine approved to date in the world for a single-use therapy.

New Gene Therapy Approval hero image

https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-hemophilia-b

ProAct Logo ProAct Logo ProAct Logo
mobile image tablet image desktop image