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FDA Advisory Panel Recommends Expanding Victoza Indications in Reducing CV Risk

June 23, 2017

An FDA advisory committee voted unanimously to recommend to the agency that a diabetic drug is not associated with excessive cardiovascular risk, and also voted 17-to-2 to recommend an added indication that it reduces heart risks in patients with type 2 diabetes.

The Endocrinologic and Metabolic Drugs Advisory Committee evaluated Novo Nordisk’s supplemental NDA for Victoza (liraglutide) and addressed data from a cardiovascular outcomes clinical trial conducted to determine postmarket safety.

Committee member Daniel Budnitz, a CDC medical officer and director of the center’s Medication Safety Program, was one of the two “no” votes on the second indication, citing the “slippery slope” of a single trial and calling for further study.

FDA reviewers noted that while differences in systolic blood pressure and body weight favored Victoza, other differences in diastolic blood pressure and heart rate favored the placebo and that there is no conclusive evidence indicating the drug improves long-term microvascular outcomes. — Zack Budryk

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