FDA OKs CSL Behring’s Idelvion

SILVER SPRING, Md. — Biotherapeutics company CSL Behring announced Friday that the Food and Drug Administration had approved its hemophilia B treatment Idelvion (coagulation factor IX (recombinant), albumin fusion protein). 

 

The drug is indicated as a routine prophylactic treatment to prevent and reduce frequency of bleeding episodes, as an on-demand bleeding control and prevention and as a perioperative management for bleeding. Certain patients can go up to 14 days between infusions of Idelvion, the company said. 

 

CSL Behring said it expects Idelvion to be available in late March.