Sobi

US FDA approves Alprolix(TM)

Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec have announced that the US Food and Drug Administration (FDA) has approved Alprolix (Coagulation Factor IX (Recombinant), Fc fusion protein), the first recombinant, DNA derived haemophilia B therapy with prolonged circulation in the body. Alprolix is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.

"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 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.

Prior to EU filing it is necessary to complete studies in paediatrics under the age of 12. Currently 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.

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About Haemophilia B
Haemophilia B is a rare, inherited disorder in which the ability of a person's blood to clot is impaired. Haemophilia B occurs in approximately one in 25,000 male births annually, and more rarely in females. The World Federation of Haemophilia global survey conducted in 2012 estimates that more than 28,000 people are currently diagnosed with haemophilia B worldwide. It is caused by having substantially reduced or no factor IX activity, which is needed for normal blood clotting. People with haemophilia B experience prolonged bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages. Prophylactic injections of factor IX can temporarily replace the missing clotting factors that are needed to control bleeding and prevent new bleeding episodes. The Medical and Scientific Advisory Council of the National Hemophilia Foundation recommends prophylaxis as the optimal therapy for people with severe haemophilia B.