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FDA committee supports expanded CV indication for liraglutide in adults with type 2 diabetes

17:38 EDT 20 Jun 2017 | Healio

An FDA advisory panel on Tuesday voted 17 to 2 in favor of an expanded indication for the GLP-1 receptor agonist liraglutide, supporting language in the prescribing information that the drug can reduce cardiovascular risk in patients with type 2 diabetes.The decision follows an analysis of primary and secondary endpoints in the LEADER trial, a randomized, double blind, placebo-controlled study conducted at 410 sites in 32 countries. The trial showed that, over a mean 3.8 years, liraglutide (Victoza, Novo Nordisk) reduced the risk for 3-point major adverse cardiac events by 13%, for all-cause death by 15% and for CV death by 22% vs. placebo, while reducing HbA1c and body weight. The FDA requires that all diabetes drugs undergo testing for CV outcomes.

Original Article: FDA committee supports expanded CV indication for liraglutide in adults with type 2 diabetes

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