CSL Behring Says HEMGENIX Receives Positive Canada Reimbursement Decision
(RTTNews) - CSL Behring Canada Inc., a business unit of Australian biotechnology company CSL Ltd. (CSL.AX, CMXHF.PK), announced Tuesday that the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) recommended public drug plan reimbursement for HEMGENIX (etranacogene dezaparvovec) for the treatment of eligible adults with hemophilia B (congenital factor IX deficiency) who require routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
The recommendation is based on results from the ongoing Phase III HOPE-B trial, which showed a one-time infusion of HEMGENIX in adult males with hemophilia B elevated factor IX activity levels and significantly reduced the rate of annual bleeds compared to routine factor IX prophylaxis with a favorable safety profile.
Hemophilia B is a rare, lifelong bleeding disorder caused by a single gene defect, resulting in insufficient production of factor IX, a protein primarily produced by the liver that helps blood clots form.
HEMGENIX is the first gene therapy for hemophilia B authorized by Health Canada. HEMGENIX has also been approved by the U.S. Food and Drug Administration, the European Commission (EC) for the European Union and European Economic Area, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and Swissmedic in Switzerland and was granted provisional approval in Australia.
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