Eloctate [antihemophilic factor (recombinant), Fc fusion protein] showed low bleeding rates in ASPIRE study- Biogen + SOBI

Newly published clinical data demonstrate that people on extended-interval prophylaxis regimens with Eloctate [antihemophilic factor (recombinant), Fc fusion protein] experienced low bleeding rates, Biogen and Swedish Orphan Biovitrum AB (Sobi) announced. The interim results of this Phase III, open-label extension study called ASPIRE were published in the online edition of Haemophilia, the journal of the World Federation of Hemophilia, the European Association for Haemophilia and Allied Disorders, and the Hemostasis & Thrombosis Research Society.

Study participants completing the Phase III A-LONG and Kids A-LONG studies were eligible to participate in ASPIRE. The results to-date show the majority of participants in ASPIRE, maintained or extended their dosing intervals between treatments compared to the A-LONG and Kids A-LONG studies. As of the interim analysis, the median time in the ASPIRE study was 80.9 weeks for adults and adolescents completing the A-LONG study, and 23.9 weeks for children completing the Kids A-LONG study. Inhibitor development is the primary endpoint of ASPIRE and no inhibitors were reported in any treatment groups. Through the interim ASPIRE analysis, adults and adolescents experienced annualized bleeding rates (ABRs) of 0.66, 2.03 and 1.97 in the individualized, weekly and modified prophylaxis arms, respectively. Children on individualized prophylaxis also experienced low bleeding rates, with an overall median ABR of 0.0 in children less than 6 years of age, and 1.54 for children ages 6 to 12. These results were consistent with data from the Phase III A-LONG and Kids A-LONG studies.

Comment: Eloctate was FDA approved in June 2014 and was filed at the EMA in October 2014.