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news.Swedish Orphan Biovitrum has received orphan drug designation for its long-lasting, fully-recombinant Factor FVIII Fc fusion protein (rFVIIIFc) from European Commission.
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The rFVIIIFc molecule, which is based on Biogen Idec’s new and proprietary monomeric Fc- fusion technology, is being investigated for the potential to prolong protection from bleeding and reduce the frequency of injections for both prophylaxis and on-demand therapy in hemophilia A.
Swedish Orphan Biovitrum and Biogen Idec are planning to advance the rFVIIIFc program into a registrational clinical trial in patients with severe hemophilia A.
Swedish Orphan Biovitrum chief scientific officer Peter Edman said that the orphan drug designation is very valuable for their rFVIIIFc project as it allows European Medicine Agency fee reduction, protocol scientific advice, and gives market exclusivity once the product is approved and receives orphan status.