Posted by Michael Wonder on 05 Jun 2018
FDA grants priority review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors
5 June 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted priority review for Hemlibra (emicizumab-kxwh) for adults and children with haemophilia A without factor VIII inhibitors.
The application is based on data from the phase III HAVEN 3 study. The FDA is expected to make a decision on approval by 4 October 2018.
In the HAVEN 3 study, adults and adolescents aged 12 years or older with haemophilia A without factor VIII inhibitors who received Hemlibra prophylaxis every week or every two weeks showed a 96% (p<0.0001) and 97% (p<0.0001) reduction in treated bleeds, respectively, compared to those who received no prophylaxis.
