Biogen Idec and Biovitrum Announce Decision to Advance Long-Acting Hemophilia B Therapy into a Registrational Trial
Hemophilia B requires frequent injections, creating a significant burden for the majority of individuals with the disorder. The potential of rFIXFc, which is based on Biogen Idec's proprietary monomeric Fc-fusion technology, to prolong protection from bleeding and reduce the frequency of injections for both prophylaxis and on-demand therapy will be evaluated in the registrational trial.
The global trial is being designed to assess the safety, pharmacokinetics and efficacy of rFIXFc in the prevention and treatment of bleeding in hemophilia B patients. The trial will commence following communications with regulatory authorities. rFIXFc has received orphan medicinal product designation for the treatment of hemophilia B from both the European (EMEA) and US (FDA) authorities.
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