CSL (ASX:CSL) has announced that the European Commission has approved IDELVION for the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
The approval follows a positive recommendation by the European Medicines Agency Committee for Medicinal Products for Human Use in late February 2016. 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.
Haemophilia B is a congenital bleeding disorder characterised by deficient or defective factor IX, nearly all affected patients are male. People with haemophilia B may experience prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs.
IDELVION, which was also recently approved in the US and Canada, delivers high-level protection maintaining factor IX activity levels above 5 per cent in most patients over 14-days. As a result, appropriate patients, age 12 and older, can go up to 14 days between infusions and achieve excellent bleeding control. This also reduces the monthly number of units needed for prophylaxis therapy.
“IDELVION provides excellent bleeding control by maintaining factor IX activity levels above 5 percent over a prolonged period of time,” said Dr Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL.
“IDELVION delivers on CSL’s 100 year promise to develop and provide innovative specialty biotherapies that patients need and want. 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 as we enter our next century.”
The company said IDELVION will be launched in European markets in the coming months, as market access and pricing are obtained.