Sobi’s partner Biogen Idec have announced that the US Food and Drug Administration (FDA) has approved Alprolix.
“The FDA approval for Alprolix will offer people with haemophilia B a new treatment option which can help reduce the burden of prophylactic injections,” said Geoffrey McDonough, President and CEO of Sobi. “We are proud to be part of this therapeutic advance through our collaboration with Biogen Idec.”
Alprolix is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B. It was recently approved by Health Canada for the treatment of haemophilia B and is currently under review by regulatory authorities in several other countries including Australia and Japan. Currently, Sobi reports, there is an ongoing phase 3 study in children with haemophilia B under the age of 12 called Kids B-LONG. Pending the outcome of the paediatric study, Sobi plans to file for market authorisation of the product in Sobi’s territories, i.e. Europe, Russia, North Africa and the Middle East.