Extended Half-Life Factor Products ALPROLIX™ and ELOCTATE™ Available to Canadians with Hemophilia
Canadian Blood Services Approves Listing and Distribution of Innovative Extended Half-Life Therapies
MISSISSAUGA, ON, Feb. 3, 2016 /CNW/ - Biogen Canada is pleased to announce the completion of successful discussions with the Canadian Blood Services (CBS) for the distribution of ELOCTATE™ [Antihemophilic Factor (Recombinant BDD), Fc Fusion Protein] and ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion Protein] for the treatment of hemophilia A and B respectively. The availability of these therapies through CBS offers new innovative treatment options for hemophilia patients in Canada.
"The Canadian Hemophilia Society (CHS) is pleased that Biogen Canada and CBS have partnered to bring ELOCTATE and ALPROLIX to the Canadian hemophilia community," said Craig Upshaw, President of the CHS. "These products are firsts in a promising new class of factor products with extended half-life and we are pleased that these are now available for Canadian patients."
"The availability of ELOCTATE and ALPROLIX through CBS offers Canadian hemophilia A and B patients, in consultation with their clinicians, new options to treat their hemophilia using a prophylactic regimen," said Dr. Alfonso Iorio, Director of the Hamilton Niagara Hemophilia Program. "The introduction of these new agents is an exciting therapeutic advancement in the management of hemophilia, and we are pleased Biogen Canada and CBS have partnered to achieve this outcome."
"We are very excited and proud that CBS and Biogen Canada have completed discussions to distribute ELOCTATE and ALPROLIX for hemophilia patients in Canada," said Paul Petrelli, VP and Managing Director of Biogen Canada.
ELOCTATE has been approved by Health Canada for routine prophylaxis to prevent or reduce the frequency of bleeding episodes and for the control and prevention of bleeding episodes in adults and children aged 12 years and older with hemophilia A.1 It is the only extended half-life treatment for hemophilia A approved in Canada shown to reduce the frequency of bleeding episodes through a prophylactic regimen of either every 3-5 days or once weekly infusions.
ALPROLIX has been approved by Health Canada for routine prophylaxis to prevent or reduce the frequency of bleeding episodes and for the control and prevention of bleeding episodes in adults and children aged 12 years and older with hemophilia B.2 It is the only extended half-life treatment for hemophilia B approved in Canada shown to reduce the frequency of bleeding episodes when dosed prophylactically either once weekly or once every 10 to 14 days.
About ALPROLIX
ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is the first long-acting fully recombinant clotting factor therapy. ALPROLIX is developed by fusing factor IX to the Fc portion of Immunoglobulin G Subclass 1, or IgG1 (protein commonly found in the body). It is believed that this enables ALPROLIX to use a naturally occurring pathway to prolong the time therapy remains in the body. While Fc fusion has been used for more than 15 years, Biogen is the only company to apply it in hemophilia.
The most common adverse drug reactions observed in the clinical trial (incidence ≥ 1%) were headaches and oral paresthesia (an abnormal sensation in the mouth).
About ELOCTATE
ELOCTATE [Antihemophilic Factor (Recombinant BDD), Fc Fusion Protein] is the first recombinant clotting factor VIII therapy with prolonged circulation in the body. ELOCTATE was developed by fusing B-domain deleted factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). It is believed that this enables ELOCTATE to use a naturally occurring pathway to prolong the time the therapy remains in the body. While Fc fusion has been used for more than 15 years, Biogen is the only company to apply it to the treatment of hemophilia. Common adverse drug reactions observed in the clinical trial (≥1%) were arthralgia (joint pain) and malaise (general discomfort).
About Biogen Canada
Biogen Canada is the Canadian affiliate of Biogen. Through cutting-edge science and medicine, Biogen discovers, develops, manufactures and markets therapies for diseases with a focus on neurology, immunology and hemophilia. Founded in 1978, with a presence in Canada since 1998, it is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis and hemophilia therapies. For press releases and additional information about the company, please visit www.biogen.ca.
1 ELOCTATE™ Product Monograph. http://www.biogen.ca/product_portfolio.aspx?ID=14979.
2 ALPROLIX™ Product Monograph. http://www.biogen.ca/product_portfolio.aspx?ID=14979.
SOURCE Biogen Canada
For media inquiries, please contact: Monique Dasilva, Sr Director, Public Affairs Biogen Inc; [email protected]; For medical inquiries, please contact: Nozhat Choudry, Director, Medical Affairs, Biogen Canada Inc; [email protected]
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