Posted by Michael Wonder on 01 Jun 2018
Idelvion newly approved 3,500 IU vial to provide convenience to patients using larger volumes
31 May 2018 - New vial option delivers on CSL Behring’s promise to enhance current treatments and provide more alternatives to patients.
CSL Behring today announced that the US FDA has approved a 3,500 IU (international unit) vial size for Idelvion [Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)], its novel, long-acting recombinant albumin fusion protein for treating haemophilia B. For some patients requiring high doses of Idelvion, the 3,500 IU vial size will reduce the reconstitution time needed to prepare multiple vials for a similar dose.
Idelvion is the first and only FDA-approved factor IX therapy that delivers zero median AsBR (annualized spontaneous bleeding rate) and is approved for up to 14-day dosing in appropriate patients. When used prophylactically, Idelvion has been shown to elevate factor IX levels to 21% at steady state.
