Bayer has received EU approval for its haemophilia A treatment Jivi.
Jivi (formerly 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, based on results from the PROTECT VIII trial.
Jivi replaces the reduced or missing FVIII in patients with the bleeding condition.
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 PROJECT VIII trial demonstrated that 74% of participants who were treated once weekly with Jivi achieved good bleed protection, compared to 100% of participants who were treated every five days.
“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.
“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 will be the third hemophilia A treatment in Bayer's haemophilia portfolio.