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Monday, May 18, 2015

PLEGRIDY Three-Year Data Support Long-Term Safety and Efficacy in MS Patients

PLEGRIDY® (Peginterferon Beta-1a) Three-Year Data Presented at AAN Annual Meeting Support Long-Term Safety and Efficacy in Multiple Sclerosis Patients
Interim Results from Phase 3 Extension Study Affirm PLEGRIDY’s Safety Profile and Robust Effect on Clinical, MRI, and NEDA Outcomes
Tuesday, April 21, 2015 7:30 am EDT
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Today Biogen (NASDAQ: BIIB) announced new data from the ATTAIN study which demonstrate the long-term safety and efficacy of PLEGRIDY® (peginterferon beta-1a) over three years in people with relapsing-remitting multiple sclerosis (RRMS). The interim results from the first year of ATTAIN, a two-year extension study of the Phase 3 ADVANCE study, show the benefits of continued PLEGRIDY treatment on clinical outcomes and further define its safety profile. The study results will be presented at the 67th American Academy of Neurology's (AAN) Annual Meeting in Washington, DC.
These data offer additional insights into the benefit-risk profile of PLEGRIDY by demonstrating a consistent safety profile and continued efficacy over three years, said Bruce Hughes, M.D., director of the Ruan Multiple Sclerosis Center at Mercy Ruan Neurology Clinic and Research Center in Des Moines, Iowa. Long-term safety and robust efficacy are important considerations when evaluating treatment options for this chronic condition.
Safety and Tolerability Results
The safety and tolerability of PLEGRIDY observed in all patients enrolled in the ATTAIN study were in line with the profile demonstrated in the ADVANCE study. The most common AEs reported were injection site reactions and flu-like symptoms, the majority of which were mild or moderate. The rate of neutralizing antibodies was one percent after three years.
Efficacy Results


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