The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has completed its meeting regarding a supplemental new drug application (sNDA) for the inclusion of data from a pivotal cardiovascular outcomes trial in the labeling for liraglutide (Victoza, Novo Nordisk) injection. The discussions at the advisory committee meeting centered on data from the LEADER trial, which involved more than 9,300 patients with type-2 diabetes at high risk of major cardiovascular events.
The advisory panel voted unanimously (19–0) in favor of liraglutide on the question: “Do the results of LEADER establish that use of Victoza in patients with type-2 diabetes is not associated with excess cardiovascular risk?”
The committee also voted 17–2 in favor of Victoza on the question: “Does the LEADER trial provide the substantial evidence needed to establish that Victoza (liraglutide) 1.8 mg reduces cardiovascular risk in patients with type-2 diabetes?”
Liraglutide is a human glucagon-like peptide-1 (GLP-1) analogue that was approved by the FDA in January 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes.
The sNDA for liraglutide was submitted to the FDA in October 2016, and regulatory feedback is expected in the third quarter of 2017.
FDA advisory committees are panels of independent experts who advise the agency on specific questions that the FDA has raised as they consider regulatory decisions. The FDA is not bound by its advisors’ recommendations, but it takes their advice into consideration when reviewing data concerning the safety and efficacy of marketed or new drugs.
The LEADER trial was an international, randomized, double-blind, placebo-controlled study investigating the long-term (3.5- to 5.0-year) effects of liraglutide (up to 1.8 mg) compared with that of placebo, both administered in addition to standard of care, in patients with type-2 diabetes who were at high risk of major cardiovascular events. Standard of care consisted of lifestyle modifications, glucose-lowering treatments, and cardiovascular medications.
The LEADER study was initiated in September 2010 and included 9,340 patients with type-2 diabetes in 32 countries. The study’s primary endpoint was the first occurrence of a composite cardiovascular outcome consisting of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
Source: Novo Nordisk; June 20, 2017.