Mississauga, ON- Bayer Inc. announced that Health Canada has granted marketing authorization for JIVI®, a recombinant DNA-derived, extended half-life Factor VIII concentrate, for previously treated patients aged 7 to under 12 years with hemophilia A (congenital Factor VIII deficiency). Authorization in patients aged 7 to under 12 years is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating JIVI’s safety and efficacy in pediatric patients with severe hemophilia A in this age range. This significant milestone reflects Bayer’s ongoing commitment to providing effective treatment options for the hemophilia community.
“The expansion of JIVI to children aged 7 to under 12 years of age in Canada provides another option for people with hemophilia A who require Factor VIII and measurable Factor VIII levels for the prevention and treatment of bleeding. I would like to recognize the Canadian patients who participated in the licensure trials for their contribution to the development of JIVI, making it available in Canada and around the world,” says Dr. Anthony Chan, pediatric hematologist at McMaster Children's Hospital and investigator of the Alfa-PROTECT study.
About JIVI®
JIVI® is indicated in previously treated adults, adolescents and children (7 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes, for control and prevention of episodic bleeding, and for peri-operative management of bleeding (surgical prophylaxis).1
JIVI was first granted market authorization from Health Canada in October 2018 for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency).
About the Alfa-PROTECT Study
Alfa-PROTECT was a Phase III, multi-national, prospective, single-arm study to evaluate the safety of JIVI infusions for prophylaxis and treatment of bleeding in previously treated pediatric patients 7 to <12 years of age with severe hemophilia A. The study evaluated the potential risk of hypersensitivity and loss of drug effect associated with an immune response to polyethylene glycol (PEG) during the first 4 exposure days to JIVI. A key secondary endpoint was the annualized bleed rate. Patients were enrolled and treated prophylactically twice weekly (40-60 IU/kg, at investigator’s discretion) for 26 weeks and at least 50 exposure days. A total of 35 patients with a median age of 8 years (range: 7 to 11) were enrolled and 32 patients completed the treatment phase and were offered continuation in an 18-month extension study.
About the PROTECT Kids Study
PROTECT Kids was a Phase III, multi-national, prospective, single-arm study to evaluate the pharmacokinetics, safety, and efficacy of JIVI for prophylaxis and treatment of bleeding in previously treated pediatric patients <12 years of age with severe hemophilia A. The primary efficacy endpoint was the annualized bleed rate.
About Hemophilia A
Hemophilia A affects fewer than 1 in 10,000 people, or about 3,900 Canadians.2 It is a largely inherited disorder in which one of the proteins needed to form blood clots is missing or reduced. Hemophilia A is the most common type of hemophilia, in which blood clotting is impaired because there is a lack or defect of coagulation Factor VIII. Patients repeatedly experience bleeds in muscles, joints or other tissues, which can result in chronic joint damage over time. Injuries can have severe consequences if not treated appropriately, as the blood clots more slowly in hemophilia patients than in healthy individuals.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.ca.
Contact for media inquiries:
Communications Department
Bayer Inc. mediacanada@bayer.com
Find more information at www.bayer.ca.
References:
1. JIVI® Canadian Product Monograph: https://www.bayer.com/sites/default/files/canada/jivi-pm-en.pdf
2. Canadian Hemophilia Society: https://www.hemophilia.ca/what-is-hemophilia
Forward-Looking Statements
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