Liraglutide is an injectable prescription drug that may improve glucose in adults with type 2 diabetes.
Novo Nordisk recently announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA completed a meeting regarding the supplemental new drug application for liraglutide (Victoza) injection.
The application was seeking to include data from the LEADER clinical trial, which measured cardiovascular outcomes for patients treated with liraglutide, according to a press release.
The FDA advisory committee was composed of a panel of independent experts who advise the agency on questions raised during regulatory decisions. While the FDA is not required to comply with the committee's recommendation, they take the committee’s findings into consideration upon review of safety and efficacy.
The LEADER clinical trial included 9340 patients with type 2 diabetes who were at high risk of developing major cardiovascular events. Patients were randomized to receive treatment with liraglutide or placebo for 3.5 to 5 years, in addition to standard care, which was comprised of lifestyle modification, glucose-lowering drugs, and cardiovascular drugs.
The primary endpoint of the trial was the first occurrence of a cardiovascular outcome comprising cardiovascular death, myocardial infarction, or stroke, according to the release.
Novo Nordisk reported that the committee voted 19-0 in favor of liraglutide related to 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 liraglutide 1.8-mg reducing cardiovascular risk among patients with type 2 diabetes, according to the release.
The application for liraglutide was submitted in October 2016, with regulatory feedback expected from the FDA in the third quarter of 2017. Novo Nordisk also submitted a type 2 variation application to the European Medicines Agency.
"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 HbA1c control in this population," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk. "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."