Kids A-Long study of Elocate for Haemophilia A success- SOBI + Biogen

Biogen Idec and Swedish Orphan Biovitrum AB (Sobi) released positive top-line results of the Kids A-LONG Phase III clinical study that evaluated the safety and efficacy of Eloctate , an investigational recombinant factor VIII Fc fusion protein product candidate, in children with severe Haemophilia A. Eloctate was generally well-tolerated and no inhibitors (neutralising antibodies that may interfere with the activity of the therapy) were detected. Efficacy analyses showed twice-weekly prophylactic dosing with Eloctate maintained low bleeding rates in children.

Kids A-LONG is the first study to evaluate a long-lasting, investigational Haemophilia therapy in children under 12 years old. Eloctate was developed using a process called Fc fusion and is designed to prolong the circulation of infused clotting factor in the body. The successful completion of this study will support applications for paediatric indications globally and is an important step to obtaining marketing authorisation in Europe. The European Medicines Agency requires the inclusion of paediatric study data in a marketing application for a new Haemophilia therapy.