CSL Behring gets U.S. FDA approval for hemophilia B therapy Idelvion

Pennsylvania-based CSL Behring, a unit of Australia's CSL, won a U.S FDA nod for Idelvion albutrepenonacog alfa (CSL654), a therapy to prevent or control bleeding in adults or children with hemophilia B. The approval follows a CHMP recommendation from the European Medicines Agency last week for marketing authorization of therapy of fusion protein linking recombinant coagulation Factor IX with recombinant albumin, the company said in a release. "Idelvion is the first and only factor IX therapy that delivers high-level protection with up to 14-day dosing in appropriate patients," the Melbourne-based parent company said. Release