EMA CHMP grants positive opinion for Biogen Idec's AVONEX PEN

Biogen Idec (NASDAQ: BIIB) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of AVONEX^® PEN^™ for patients with relapsing multiple sclerosis (MS) and patients with a single demyelinating event. The CHMP recommendation provides the basis for a European Commission licensing decision, which is expected within 75 days from the opinion. The company also announced an authorisation for AVONEX PEN from Health Canada.

“AVONEX is currently one of the most prescribed first-line treatments for people living with MS and has more than 1.4 million patient years of experience. For many patients and their caregivers, AVONEX PEN is a significant advancement, especially for those who desire a more convenient method of administration”

AVONEX PEN is designed to be the first single-use, once-a-week, fully integrated intramuscular autoinjector available for use with AVONEX treatment. It has been designed to improve convenience of AVONEX administration, while also reducing injection anxiety. The CHMP decision was based, in part, on a Phase 3b study in which the overall success rate in using AVONEX PEN in patients with MS was 89 percent. In the study, 94 percent of patients expressed a preference for AVONEX PEN over the AVONEX Prefilled Syringe.

"AVONEX is currently one of the most prescribed first-line treatments for people living with MS and has more than 1.4 million patient years of experience. For many patients and their caregivers, AVONEX PEN is a significant advancement, especially for those who desire a more convenient method of administration," said Douglas E. Williams, Ph.D., executive vice president, research and development at Biogen Idec. "This positive CHMP opinion and authorisation in Canada is a testament to our commitment to not only develop new treatments for the MS community, but our continued drive to further improve patients' experience with our existing industry-leading therapies."