Bayer's Jivi garners EU approval for treatment, prophylaxis of haemophilia A

Bayer said Tuesday that the European Commission approved the recombinant Factor VIII (rFVIII) replacement therapy Jivi for the treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with haemophilia A. The therapy, formerly known as BAY94-9027, was authorised in the US in August and in Japan the following month.

According to Bayer, the European approval was supported by data from the PROTECT VIII trial of previously treated adults and children at least 12 years old with severe haemophilia A. Results from the study showed that 74 percent of patients who received one dose of Jivi weekly, and all patients who received the drug every five days experienced good bleed protection, including a median annualised bleed rate of 0.96 in the once-weekly group.

Jivi was also cleared last month in Canada for use in patients with haemophilia A, with Bayer noting that the therapy is its third approved treatment for haemophilia A in its portfolio. The rFVIII product Kovaltry was authorised in Europe in 2016.