US-based Biogen Idec has received approval from Health Canada for Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein], for the control and prevention of bleeding episodes and routine prophylaxis in adults and children aged 12 and older with haemophilia B.
Haemophilia B is a rare, chronic, inherited disorder where the ability of a person’s blood to clot is impaired, which can lead to recurrent and extended bleeding episodes and is due to a substantial reduction of, or no factor IX activity, which is needed for normal blood clotting.
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The first approved long-acting haemophilia B therapy, Alprolix, is indicated to prevent or reduce the frequency of bleeding episodes with prophylactic (protective) infusions starting at once weekly or once every ten to 14 days.
Alprolix is currently under review by regulatory authorities in several other countries, including the US, Australia and Japan.
Biogen Idec chief executive officer George Scangos said Health Canada’s approval of Alprolix marks the first significant treatment advance in hemophilia B in 17 years.
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"We believe that the safety, efficacy and prophylactic dosing schedule demonstrated with Alprolix will provide people with hemophilia B a meaningful new way to manage their condition," Scangos said.
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By GlobalDataThe approval is based on results from the global, Phase III B-LONG study, which showed that Alprolix safely and effectively prevented, or reduced, bleeding episodes with prophylactic infusions given once weekly or once every ten to 14 days in adults and adolescents with severe haemophilia B.
In addition, more than 90% of all bleeding episodes were controlled by a single Alprolix infusion.
The Hospital for Sick Children pediatric hematologist and comprehensive care hemophilia programme co-director Manuel Carcao said Health Canada’s approval of Alprolix provides people with hemophilia B a new option in maintaining a prophylactic regimen.
"Alprolix, the first approved long-acting factor concentrate, has been shown to help individuals with hemophilia B achieve effective bleed prevention with prophylactic dosing once a week or once every ten to 14 days," Carcao said.
The World Federation of Hemophilia also recommends a prophylactic regimen as the goal of treatment for people with severe haemophilia.
The company is working with Canadian Blood Services, the Service de Biovigilance du Ministère de la Santé et des Services sociaux and other provincial and national authorities in order to make Alprolix commercially available to all Canadians with haemophilia B.
Image: Deficiency in coagulation factor VIII is the most common cause of haemophilia. Photo: courtesy of ProteinBoxBot.
