December 10, 2018

Bayer’s pegylated EHL now licensed

Bayer’s pegylated extended half life factor VIII damoctocog alfa pegol (Jivi) has now been formally licensed by the European Medicines Agency for the treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with haemophilia A.

Approval is based on the PROTECT VIII trial, which showed that prophylaxis with damoctocog alfa pegol administered every 5 days (but not weekly) significantly reduced bleeding rates over 6 months. Outcomes in 33 patients who completed 5 years of prophylaxis, reported at the 60thAnnual Meeting of the American Hematology Society in San Diego, demonstrated continuing effectiveness, no new safety signals and no emergence of inhibitors.