Biogen Idec Blood Disorder Drug Registers Positive Outcomes for Phase 3 Trials
Biogen Idec and Swedish Orphan Biovitrum AB have registered positive outcomes for phase 3 trials of experimental drug for hemophilia A. The clinical trial has found high success rate among children suffering from blood disorder in maintaining low bleeding rates.
Biogen Idec announced that the experimental drug ELOCTATE was tested for efficacy and safety in the clinical trial carried out of children under 12 years of age. Swedish Orphan Biovitrum developed using Fc fusion process. The drug claims to prolong the circulation of infused clotting factor.
In cases of severe hemophilia A cases, the drug managed to increase the half life by 1.5 times compared to A-LONG study carried out for adolescents and adults. The study registered median ABR of 2.0 and a median ABR for spontaneous bleeds of 0.0 for children administered ELOCTATE.
Kids A-LONG is a global, open-label, multiple location Phase 3 study involving 71 boys with severe haemophilia A. Eloctate was reportedly well-tolerated among study subjects.
Birgitte Volck, M.D., Ph.D., senior vice president development and chief medical officer of Sobi. "The successful completion of the Kids A-LONG study in children under 12 years old is an important step to bringing this potential new treatment option to adults and children with haemophilia A and a milestone that will enable regulatory submission in Europe."
The companies will now proceed with application for approval from European Medicines Agency.
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