European Commission approves Jivi for the treatment and prophylaxis of bleeding in patients with hemophilia A. Bayer HealthCare

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 C� 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.

About PROTECT VIII study: The study demonstrated that 74 percent of participants who were treated once weekly with BAY94-9027, and all (100 percent) 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.