Victoza Receives Positive Vote from FDA Advisory Committee

Novo Nordisk announced the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has completed its meeting regarding the supplemental New Drug Application (sNDA) for inclusion of the data from the cardiovascular outcomes trial LEADER in the label of Victoza (liraglutide) injection 1.2 mg or 1.8 mg. 

The discussions at the Advisory Committee meeting were based on data from the LEADER trial, which involved more than 9,300 people with type 2 diabetes at high risk of major cardiovascular events.

The Advisory Committee voted unanimously 19-0 in favor of Victoza 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 Advisory Committee 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?"

"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."

The sNDA for Victoza was submitted to the FDA in October 2016 and regulatory feedback in the US is expected in Q3 2017. In Europe, a Type II Variation application was submitted to the European Medicines Agency (EMA) in October 2016.

FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing data concerning the safety and effectiveness of marketed or new drug applications.

LEADER was a multicenter, international, randomized, double-blind, placebo-controlled trial investigating the long-term (3.5–5 years) effects of Victoza (liraglutide up to 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of major cardiovascular events. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.

LEADER was initiated in September 2010 and randomized 9,340 people with type 2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.