Positive Ph III results from Biogen Idec and SOBI's Alprolix in pediatric study

US biotech major Biogen Idec (Nasdaq: BIIB) and Nordic drugmaker Swedish Orphan Biovitrum (STO: SOBI) have announced positive top-line results of the Kids B-LONG Phase III clinical study that evaluated the safety, efficacy and pharmacokinetics of Alprolix (coagulation Factor IX [Recombinant], Fc fusion protein) in children under age 12 with severe hemophilia B.

Biogen Idec  gained US approval for the use of Alprolix in adults and children who have hemophilia B nearly a year ago. The drug generated revenues of $76 million in 2014. The drug is also approved in Canada, Japan and Australia. Consensus sales alongside partner Swedish Orphan Biovitrum are forecast to reach $214 million by 2018, according to health care analyst Evaluate. However, GlobalData forecasts that peak-year US sales of Alprolix will reach $786 million and $349 million by 2022.

Alprolix was generally well tolerated and no inhibitors (neutralizing antibodies that may interfere with the activity of the therapy) were detected during the study. In this study, once-weekly prophylactic dosing with Alprolix resulted in low bleeding rates. Alprolix is the only approved hemophilia B therapy with prolonged circulation in the body.