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news.Biogen Idec and Swedish Orphan Biovitrum plan to initiate a global pediatric trial of fully-recombinant Factor IX Fc fusion protein (rFIXFc) in previously-treated patients under 12 years of age as soon as sufficient data are available from a study of older patients, in accordance with the European Medicines Agency’s (EMA) Pediatric Committee (PDCO) opinion.
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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.