Teva Pharmaceuticals announced initial results from its Phase 3 BRAVO study of laquinimod for the treatment of multiple sclerosis (MS). BRAVO is the second of two Phase 3 studies in the clinical development program for the treatment of relapsing-remitting multiple sclerosis (RRMS). Results showed that the BRAVO study did not achieve its primary endpoint of reducing the annualized relapse rate (P=0.075).
The randomization process for BRAVO was adequately performed; however, placebo and treatment study groups showed dissimilarity in two baseline magnetic resonance imaging (MRI) characteristics. According to a standard and pre-specified sensitivity analysis included within the original statistical analysis plan, when this imbalance was corrected laquinimod demonstrated a significant reduction in the annualized relapse rate (21.3%, P=0.026), in the risk of disability progression as measured by Expanded Disability Status Scale (EDSS) (33.5%, P=0.044) and in brain volume loss (27.5%, P<0.0001). Teva plans to submit applications to regulatory authorities in the U.S. while additional analyses of the BRAVO study data are ongoing.
Laquinimod is an oral, once-daily immunomodulator with a novel mechanism of action being developed for the treatment of MS.
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