rFIXFc is a recombinant Factor IX Fc fusion protein developed using monomeric Fc fusion technology.
It is a clotting factor designed to replace the protein that hemophilia B patients lack and to last longer in the body than available Factor IX products.
Swedish Orphan Biovitrum CSO Peter Edman said the opinion from the EMA’s PDCO is valuable for their rFIXFc project, as it allows for the development of rFIXFc in the pediatric population.
Biogen senior vice president Glenn Pierce said with this opinion and the ongoing Phase 3 trials of their long-lasting Factor IX and Factor VIII programs, they continue to make progress toward their goal of improving the way hemophilia is treated worldwide.