- Extended half-life product that offers a reduction in dosing frequency and improved bleeding protection
- May be adjusted to every five days and further individually adjusted to less or more frequent dosing
MISSISSAUGA, ON, Oct. 24, 2018 /CNW/ - Bayer Inc. announced today that Health Canada has approved Jivi® (Antihemophilic Factor [Recombinant, B-domain deleted, PEGylated]) for routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in previously treated adults and adolescents 12 years of age or older. Health Canada also approved Jivi for control and prevention of episodic bleeding, and peri-operative management of bleeding (surgical prophylaxis.)1
The recommended initial prophylactic regimen for Jivi is twice weekly, with the ability to dose every five days and further individually adjust to less or more frequent dosing based on bleeding episodes. This approval is based on results from the PROTECT VIII trial.
"In Canada, approximately 2,500 people live with hemophilia A2. It is a rare disease where one of the proteins needed to form blood clots is missing or reduced and patients struggle to manage bleeds," said Dr. Alfonso Iorio, professor and researcher of the Department of Health Research Methods, Evidence, and Impact and the Department of Medicine at McMaster University. "Research shows Jivi's novel structural design produces very predictable pharmacokinetics (the way the drug moves through the body). This makes it simpler to build effective treatment regimens and minimize the infusion frequency."
"We welcome the approval of Jivi by Health Canada," said Paul Wilton, president, Canadian Hemophilia Society. "This will add another option for patients with hemophilia A in selecting the factor VIII replacement therapy that is right for them."
About Jivi® (Antihemophilic Factor [Recombinant, B-domain deleted, PEGylated])
Jivi® was engineered to have an extended half-life by harnessing proven PEG-technology that delivers higher sustained levels of FVIII, which extends the blood's ability to coagulate for longer.
Jivi is a rFVIII replacement therapy, meaning it replaces the reduced or missing FVIII in adults and adolescents 12 years of age or older with hemophilia A. As a site-specifically PEGylated FVIII, Jivi has a half-life of 18.6 hours. rFVIII replacement therapy is the standard of care to stop or prevent bleeding and has proven efficacy and safety established over decades of clinical trials and real-world experiences.
About PROTECT VIII study
The Health Canada approval of Jivi is supported by results from the pivotal PROTECT VIII trial comprised of prophylactic dosing, on-demand treatment, and perioperative management in previously treated adults and adolescents 12 years of age or older with severe hemophilia A.
The PROTECT VIII study was a 36-week, international, open label trial. Overall, 126 patients completed the main study. Part A evaluated pharmacokinetics, efficacy and safety of Jivi for on-demand treatment of bleeds and for prophylactic therapy at different dosing regimens. An optional extension study was available to subjects who completed Part A to assess Jivi over at least 100 accumulated exposure days, which demonstrated bleed protection and a good safety profile of up to a median of 1.9 years (range of 0-2.6 years). Part B evaluated safety and efficacy of Jivi during major surgery. Treatment with Jivi was generally well tolerated. The most frequently reported (≥5%) adverse reactions in clinical trials in previously treated patients were headache, cough and pyrexia.
About Bayer in Hemophilia
Bayer is driven by helping people with hemophilia thrive. We have a deep understanding of the evolving needs and aspirations of people with hemophilia, established over 25 years of partnering with the hemophilia community. FVIII replacement treatments are the standard of care to stop or prevent bleeding. Bayer's portfolio of FVIII treatments, including Kovaltry, and now Jivi, offers people with hemophilia A across all stages of life a treatment to suit their individual needs and lifestyles...
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