Jerusalem: Teva Pharmaceutical Industries and Active Biotech will discontinue higher doses of their oral drug in development for multiple sclerosis in two trials, citing the occurrence of non-fatal cardiovascular events in eight patients.
Both trials of laquinimod will continue with the lower dose of 0.6 mg daily where there were no issues.
Israel-based Teva and Sweden’s Active Biotech said a monitoring committee had identified an imbalance in the number of cardiovascular events in patient trials using 1.2 mg and 1.5 mg daily doses.
“Teva is notifying trial sites to discontinue the higher doses immediately in both trials and will encourage participants to continue follow ups,” it said in a statement on Monday.
Through a licensing agreement, Teva has global rights to develop and commercialise laquinimod, a small-molecule entity discovered by Active Biotech.