Biogen Idec and AbbVie Announce Positive Top-Line Results from Phase 3 Study Investigating Daclizumab High-Yield Process in Multiple Sclerosis

June 16, 2014

Today Biogen Idec (BIIB) and AbbVie (ABBV) announced positive top-line results from the Phase 3 DECIDE clinical trial, designed to evaluate the superiority of once-monthly, subcutaneous daclizumab high-yield process (DAC HYP) when compared to intramuscular interferon beta-1a (IFN β-1a), as a potential treatment for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). Results showed that DAC HYP was superior on the study’s primary endpoint, demonstrating a statistically significant 45 percent reduction in annualized relapse rate (ARR) compared to IFN β-1a (p < 0.0001).

“The results of the DECIDE study are compelling, with DAC HYP demonstrating robust efficacy compared to a current standard of MS care,” said Gilmore O’Neill, vice president, Global Neurology Clinical Development, Biogen Idec. “As a potential once-monthly therapy with a novel mechanism of action, we believe that, if approved, DAC HYP will be an important treatment option for people living with MS.”

“The positive results in the DECIDE study represent achievement of an important milestone in the development of DAC HYP as a potential new treatment option for MS patients,” said Michael Severino, M.D., executive vice president, Research and Development and chief scientific officer, AbbVie. “Together, the companies are committed to working with regulatory agencies on filing plans for DAC HYP.”

Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews