Cardiac Issues Associated with High-Dose Drug Trial

Teva PharmLast week, Teva Pharmaceutical Industries Ltd. and Active Biotech AB announced they were ending the higher-dose portions of two multiple-sclerosis medication studies. The decision came after eight patients suffered nonfatal cardiovascular events after taking laquinimod.

According to the company, the incidents occurred during a Phase II and Phase III of a clinical trial involving  higher dose (1.2 mg) components. Typically, Phase III clinical trials are the last phase before receiving approval from the U.S. Food and Drug Administration. Laquinimod is designed to be taken orally once a day to treat multiple sclerosis and Huntington’s disease.

Zintro expert Aliya Arinova CTM, PM is a clinical trial specialist. Arinova questions why the problems weren’t identified earlier in the study, explaining, “Preclinical and Phase 1 teams should capture the potentially negative effects prior to launching the compound into the next phases.” Teva plans to continue the trials of 0.6 mg doses.

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