Novo Nordisk seeks broad primary prevention claim, EMDAC recommends drug for patients with established CV.
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has rendered a decision on the supplemental New Drug Application (sNDA) of Novo Nordisk’s liraglutide (Victoza) injections for the treatment of type 2 diabetes.
EMDAC members based their votes on results of the LEADER trial, which investigated the effects of liraglutide compared to placebo in 9,340 patients with type 2 diabetes at high risk for cardiovascular events.
All 19 members agreed that LEADER’s results established that the use of liraglutide in patients with type 2 diabetes is not associated with excess cardiovascular risk.
17 members agreed, and 2 disagreed that LEADER provided the substantial evidence needed to establish that 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.”
While EMDAC’s decisions largely fell in Novo Nordisk’s favor, the pink sheet notes that at least some of EMDAC’s panelists recommended that the drug’s indication be limited to patients with type 2 diabetes who had established cardiovascular disease, and not the broad primary prevention claim that Novo Nordisk is interested in obtaining.
According to the pink sheet, some panelists did not believe that Novo Nordisk has strongly demonstrated benefits in patients who fall in the lower risk group, and that liraglutide should only be indicated for those who have high cardiovascular risk.
EMDAC is a panel of independent experts who advise the FDA on specific questions they raise when considering regulatory decisions.
The sNDA for liraglutide was submitted to the FDA in October 2016. Regulatory feedback in the US is expected in Q3 2017. Novo Nordisk submitted a Type II Variation application to the European Medicines Agency (EMA) in October 2016.
The FDA does not have to follow EMDAC’s recommendation for approval, but historically, it has.
Liraglutide is a 1.2 mg or 1.8 mg injectable prescription medicine that should be used along with diet and exercise to improve blood glucose levels in adults with type 2 diabetes. It is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the FDA in 2010.
The drug has been shown to cause serious side effects, including possible thyroid tumors, pancreatitis, hypoglycemia, kidney failure, and serious allergic reactions.