Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) today announced that the European Medicines Agency's (EMA) Pediatric Committee (PDCO) has adopted an opinion agreeing to the pediatric investigational plan for the companies' long-lasting, fully-recombinant Factor IX Fc fusion protein (rFIXFc).
In accordance with the PDCO's opinion, Biogen Idec and Swedish Orphan Biovitrum plan to initiate a global pediatric trial in previously-treated patients under 12 years of age as soon as sufficient data are available from a study of older patients. Under draft guidelines published by the EMA for the development of Factor IX products, pediatric data from this trial will be required in the initial submission of a Marketing Authorization Application to the European regulatory agency.
"The EMA's agreement to our pediatric investigational plan is another milestone in our effort to develop innovative therapies for people with hemophilia," said Glenn Pierce, M.D., Ph.D., Senior Vice President of Hemophilia at Biogen Idec. "With this opinion and the ongoing Phase 3 trials of our long-lasting Factor IX and Factor VIII programs, we continue to make progress toward our goal of improving the way hemophilia is treated worldwide."
"The opinion from the EMA's Pediatric Committee is valuable for our promising rFIXFc project, as it allows for the development of rFIXFc in the pediatric population. We are excited about the potential of this innovative product to make a difference in the lives of people with hemophilia," said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum.
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