FDA Panel Gives Liraglutide Nod for CV Indication


Liraglutide, a GLP-1 receptor agonist sold as Victoza, becomes the second diabetes therapy to receive the cardiovascular indication.

An FDA advisory panel voted late Tuesday to update the label for the type 2 diabetes (T2D) liraglutide to state that it can lower cardiovascular (CV) risks for high-risk patients.

Liraglutide, the glucagon-like peptide-1 (GLP-1) receptor agonist sold by Novo Nordisk as Victoza, received a 17-2 vote from FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The vote was based on results from the LEADER trial, which found a 22% reduction in the risk of CV death in high-risk patients and reduced all CV events by 13%.

If FDA approves the indication, liraglutide will become the second T2D drug and the first GLP-1 therapy to receive an indication that it can reduce CV events for high-risk patients. Empagliflozin, a sodium glucose cotransporter-2 (SGLT2) inhibitor sold as Jardiance, was the first to receive this indication in December 2016.

Canagliflozin, the SGLT2 inhibitor sold by Janssen as Invokana, presented results at last week’s meeting of the American Diabetes Association showing a 14% reduction in cardiovascular events. Janssen has said it plans to seek a similar indication with FDA.

The panel took 2 votes on liraglutide. The first, which was 19-0, asked if the results of LEADER showed that the drug was not associated with any excess cardiovascular risk. The 17-2 vote asked if LEADER showed that there was “substantial evidence” to show that liraglutide’s 1.8 mg dose “reduces cardiovascular risk in patients with type 2 diabetes.”

Liraglutide is available in 1.2 mg and 1.8 mg injections.

“Cardiovascular disease is the number one cause of death for people with type 2 diabetes, and today’s discussion is an important reminder that there is an unmet need to provide benefits beyond (A1C) control in this population,” Todd Hobbs, MD, vice president and chief medical officer of Novo Nordisk, said in a statement. “The positive vote from EMDAC puts us one step closer to expanding our offering to reduce the risk of cardiovascular events in people with type 2 diabetes.”

The clinical trials that led to the indications were designed only to show that the diabetes drugs were safe. Results showing they reduced CV events were unexpected, and since the results for empagliflozin were announced, a trial for an investigational therapy, ertugliflozin, has expanded to find out whether it, too, prevents heart attacks, strokes, and CV deaths.

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