Teva Pharmaceuticals has dropped a trial of Laquinimod, its multiple sclerosis (MS) medicine, after a series of non-fatal cardiovascular events, Globes reported on Monday.
Teva and Active Biotech announced the discontinuation of higher doses of Laquinimod after heart trouble occurred in eight patients.
The data monitoring committee (DMC) overseeing two active clinical studies in MS recommended a halt to the study of patients taking a daily dose of Laquinimod at 1.2 mg for treatment of relapsing-remitting MS (RRMS) in the CONCERTO trial. Teva is notifying trial sites to discontinue the higher doses immediately.
The lower-dose trials (0.6 mg daily), and participants in the trials will be provided with an update to confirm re-consent for participation. The DMC did not identify a cardiovascular signal with the lower dose but recommended long-term monitoring.
Through a licensing agreement, Teva has global rights to develop and commercialize Laquinimod, a small-molecule entity discovered by Active Biotech.