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The long-acting rFIXFc product is based on Biogen Idec's proprietary monomeric Fc-fusion technology.
The decision was based on promising data from a Phase I/II open-label, multi-center, safety dose-escalation and pharmacokinetic trial of rFIXFc in severe, previously-treated hemophilia B patients. The product was well tolerated and also showed a prolonged half-life compared to historical data for existing therapies, Biovitrum said.
The global trial is being designed to assess the safety, pharmacokinetics and efficacy of rFIXFc in the prevention and treatment of bleeding in patients.
The rFIXFc product has received an orphan medicinal product designation for the treatment of hemophilia B from the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA).
The study will start following communications with regulatory authorities.
Hemophilia B occurs in about one to 25,000 male births annually and it is caused by having substantially reduced or no factor IX protein, which is needed for normal blood clotting.
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