Disappointing BRAVO Data Raise Doubts About Laquinimod's Chances With FDA
This article was originally published in The Pink Sheet Daily
BRAVO goes to show that placebo event rates may be lower than expected in MS trials and that outcomes are tough to predict, say analysts.
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FDA casts a vote of confidence in Actelion's Phase III trial design for its oral multiple sclerosis candidate ponesimod, while Teva loses its special protocol assessment for laquinimod after dosing changes. Plus more regulatory clinical trial news in brief.
Teva will discontinue higher doses of laqunimod in two ongoing studies for multiple sclerosis after cardiovascular events were experienced in eight patients. Trials will continue with a lower dose.
Teva has ambitions to file in 2018 after the Phase III CONCERTO trial reads out in 2017. Firm is studying a higher dose of the drug and relying on a different primary endpoint, hoping to show stronger efficacy over a Phase III trial that failed in 2011.