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Wednesday, September 28, 2016

Change in Clinical Test Dose of Potential MS Therapy, Laquinimod, Triggers FDA Response


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Active Biotech acknowledged in an update on laquinimod, the oral small molecule being developed by Teva Pharmaceutical Industries to treat multiple sclerosis (MS) and Huntington’s disease (HD), that the U.S. Food and Drug Administration (FDA) has rescinded the special protocol assessment given to a Phase 3 study of the treatment in relapsing MS patients because of a dose change that — necessarily, the company said — was made without prior FDA approval.
Laquinimod, which Active and Teva are working together to develop, is being evaluated for safety, efficacy and tolerability in the CONCERTO study (NCT01707992), a double-blind and placebo-controlled trial that was investigating two oral doses of laquinimod — 0.6 mg/day or 1.2mg/day — in relapsing MS patients. But the Data Monitoring Committee (DMC) supervising this trial and a similar study in progressive MS patients recommended use of higher doses be discontinued immediately in January, after cardiovascular events were reported in eight patients (none fatal) — seven in the relapsing MS and one in the progressive MS studies.

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