FDA approves CSL Behring’s new haemophilia B treatment
pharmafile | March 7, 2016 | News story | Research and Development, Sales and Marketing | CSL Behring, haemophilia
The US Food and Drug Administration (FDA) has approved CSL Behring’s Idelvion (Coagulation Factor IX (Recombinant)), a novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment of haemophilia B.
The congenital bleeding disorder affects mostly males and approximately one in 25,000 males suffer from the condition, according to the US Centers for Disease Control and Prevention (CDC). It is characterised by deficient or defective blood clotting factor IX and those with the condition may experience prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs.
Idelvion delivers high-level protection with up to 14-day dosing in appropriate patients, and is the first medicine to do so. It has already been approved in Canada and was recently recommended by the European Medicine Agency’s Committee for Medicinal Products for Human Use.
It has been indicated in the US in children and adults with haemophilia B for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand control and prevention of bleeding episodes; and the perioperative management of bleeding around the time of surgery.
Dr Andrew Cuthberston, chief scientific officer and R&D director at CSL, comments: “Idelvion has the potential to significantly impact the treatment of haemophilia B, as it maintains factor IX activity levels above 5% over a prolonged period of time. This provides excellent bleeding control. Idelvion is the first product from our innovative recombinant factor development program to receive FDA approval. We are proud to add this new therapy to our growing portfolio of bleeding disorder products.”
Idelvion is expected to be available in the US later this month.
Sean Murray
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