Bayer announced that Jivi (BAY94-9027) has been approved by the European Commission for the treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with hemophilia A. The recommended prophylactic regimen for Jivi is every five days or, based on patient clinical characteristics, can also be every 7 days or twice weekly. The approval is based on results from the PROTECT VIII trial.“Infusion frequency is a major challenge for people with hemophilia A and we believe with Jivi we can address those needs without compromising good bleed protection,” said Dr Elena Santagostino, director of the Hemophilia Unit for adult and paediatric patients with inherited bleeding disorders at the Angelo Bianchi Bonomi Hemophilia and Thrombosis Centre of the Cà Granda Foundation, Maggiore Hospital Policlinico of Milan, Italy. “With the opportunity to offer a treatment with sustained levels of FVIII for a longer period in the blood and thus provide good bleed protection, patients and family members can feel confident that they or their loved one is well protected from bleeds and can spend more time enjoying a wider range of activities together.”This is a major approval for Jivi this year following that from the FDA and the more recent approval received in Japan. Jivi is the third hemophilia A treatment in Bayer’s hemophilia portfolio.Jivi is a recombinant Factor VIII (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 rFVIII, it achieves sustained high-levels of FVIII. FVIII 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.The EU approval is based on the results of 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 study demonstrated that 74 per cent of participants who were treated once weekly with BAY94-9027, and all (100 per cent) participants who were treated every five days achieved good bleed protection. The patients who stayed on the once weekly regimen in the study had a median annualized bleed rate (ABR) of 0.96; half of them experienced 0 bleeds. Treatment with BAY94-9027 was generally well tolerated both prophylactically and on-demand.A good safety and efficacy profile has been maintained during more than 5 years of experience during the PROTECT VIII and extension studies. In the PROTECT VIII extension trial, the overall ABR for patients was reduced in comparison to the PROTECT VIII main trial. No patient developed inhibitors and no safety issues were identified.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 therapy is the standard of care to stop or prevent bleeding. Bayer’s portfolio of FVIII treatments offers people with hemophilia A across all stages of life a treatment to suit their individual needs and lifestyles. We work together with researchers, healthcare professionals and patient groups to build a strong community and help people with hemophilia to live fulfilling lives. Bayer is passionate about spearheading research and investing in developing the next generation of therapies and solutions to help people with hemophilia thrive in the future.
The European Commission has given its approval to Bayer's Jivi treatment for patients with haemophilia A. Bayer has now received approval from EU and regulators in Japan. Jivi is the third treatment in Bayer's haemophilia portfolio. The the US Food and Drug Administration's approval was based on a study which showed 100% success in patients treated every five days and a 74% success rate in those dosed weekly, in terms of bleed protection.