New safety analysis of Nerventra in MS-Teva/Active Biotech

Teva Pharmaceutical and Active Biotech have announced new follow-up data evaluating the clinical safety of Nerventra (laquinimod) in patients with relapsing-remitting Multiple Sclerosis (RRMS) who were treated with laquinimod in Phase II, Phase III and open-label extension studies for two or more years. The pooled safety analysis of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies supports findings observed in the core studies where currently identified risks were observed within the first months of laquinimod treatment.

In the pooled safety analysis, rates of adverse events (AEs) and serious AEs were lower in the open-label extensions than in the core studies and less than three percent of patients discontinued treatment due to AEs during these extensions. Additionally, shifts to potentially significant laboratory values were considerably lower in patients exposed to at least two years of laquinimod (1.18% reached >3xULN ALT vs. 4.72% for laquinimod and 2.6% for placebo during the core study). These data will be presented at the MS Boston 2014 conference.