Factor appears safe, effective in hemophilia B

Next steps

Based on the overall favorable outcomes of this study, Biogen Idec and Sobi are planning to submit a Biologics License Application for rFIXFc to the FDA in the first half of 2013. They also plan to submit an application to the EMA following results of a similar study in children, called Kids B-LONG.

Kids B-LONG is a phase 3, open-label study in previously treated children who are younger than 12 years of age and have been diagnosed with hemophilia B. The study is actively recruiting patients.

Researchers are also evaluating rFIXFc in the B-YOND study, which is a long-term, open-label extension study for patients who completed the B-LONG study or who will complete the Kids B-LONG study.