EU approves Idelvion for haemophilia B treatment

pharmafile | May 13, 2016 | News story | Medical Communications, Research and Development CSL, EU, Idelvion, approval, haemophilia B 

The European Commission has approved Idelvion, coagulation Factor IX (recombinant) for the treatment and prophylaxis of bleeding in patients with haemophilia B.

Approved in children and adults, the indicated 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.

Also recently approved in the US and Canada, Idelvion has demonstrated efficacy in maintaining Factor IX activity levels above 5% in most patients over 14 days.

Dr Andrew Cuthbertson, chief scientific officer at CSL, says: “Idelvion provides excellent bleeding control by maintaining factor IX activity levels above 5% over a prolonged period of time… We look forward to bringing Idelvion to the European market and are particularly excited about the positive impact this long-acting therapy can have on the lives of patients with haemophilia B.”

Sean Murray

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