Daclizumab high-yield process superior to Interferon beta-1a for Relapsing Remitting MS - Biogen/Abbvie

Biogen Idec and AbbVie announced positive top-line results from the Phase III 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 beta-1a) ,as a potential treatment for Relapsing-Remitting Multiple Sclerosis (RRMS), the most common form of Multiple Ssclerosis (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 beta-1a (p<0.0001). dac hyp showed superiority on the first secondary endpoint number of new or newly enlarging t2-hyperintense lesions at week 96 with a 54 percent reduction relative to ifn beta-1a p><0.0001). on the second secondary endpoint dac hyp reduced the risk of three month confirmed disability progression as measured by the expanded disability status scale edss by 16 percent over ifn beta-1a which was not statistically significant p="0.16)." using a pre-specified sensitivity analysis that accounted for 67 patients who did not have a confirmatory disability assessment dac hyp showed a 21 percent reduction in the risk of sustained disability progression p="0.047)." the safety profile of dac hyp in the study was consistent with what has been observed in prior studies.>