Daclizumab meets RRMS endpoint

Biogen Idec Inc. (NASDAQ:BIIB) and partner Abbott Laboratories (NYSE:ABT) said once-monthly subcutaneous daclizumab met the primary endpoint of annualized relapse rate compared to placebo in the Phase IIb SELECT trial to treat relapsing-remitting multiple sclerosis. Specifically, low- and high-dose daclizumab reduced ARR by 54% and 50%, respectively, vs. placebo at one year from baseline (p<0.0001 and p=0.0002, respectively). The double-blind, international trial enrolled 600 patients.

There was one death in SELECT due to a complication of a psoas muscle abscess in a patient recovering from a serious skin adverse event and one death in the ongoing SELECTION extension study due to possible autoimmune hepatitis. The partners said that daclizumab's role in both deaths could not be excluded. ...