Teva Pins Long-Term Hopes In MS On The Return Of Laquinimod
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.
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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.
Roche plans to file the selective CD20 antibody in 2016 after releasing positive Phase III data at ECTRIMS in both relapsing-remitting and primary progressive multiple sclerosis, a debilitating form of the disease for which there are no approved drugs.
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.