Swedish Orphan Biovitrum's Hemophilia A Therapy Receives European Commission Orphan Drug Designation
Swedish Orphan Biovitrum announced that the European Commission has granted Orphan Drug Designation to its long-lasting, fully-recombinant Factor FVIII Fc fusion protein (rFVIIIFc), which is partnered with Biogen Idec. It was recently announced that the companies plan to advance the rFVIIIFc program into a registrational clinical trial in patients with severe hemophilia A.
Treatment of severe hemophilia A requires frequent infusions, creating a significant burden for individuals with the condition. The rFVIIIFc molecule, which is based on Biogen Idec's novel 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.
"The orphan drug designation is very valuable for our promising and high-opportunity 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. This will help us in our efforts to bring this innovative rFVIIIFc product to hemophilia patients," said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum.
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