CSL's Idelvion gets EC approval and seven years exclusivity in USA

The European Commission has now approved Idelvion (coagulation Factor IX [recombinant], albumin fusion protein), from Australia’s CSL Limited (ASX: CSL), for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency).

The move follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation to grant marketing authorization Idelvion (The Pharma Letter February 26).

Idelvion can be used for all age groups (children and adults). The approved treatment regimen includes routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand control; and the perioperative management of bleeding (around the time of surgery).