The drug will receive a ruling on Aug. 25. It's currently approved to treat type 2 diabetes and obesity.
The US Food and Drug Administration is set to make a decision on the approval of Novo Nordisk’s liraglutide (Victoza) injection for the treatment of cardiovascular risk in adults with type 2 diabetes.
The ruling is set for Aug. 25. In June, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted to recommend liraglutide by a count of 17 to 2.
The drug was tested to reduce the risk of major adverse cardiovascular events such as nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death. The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial provided evidence of a 13% reduction in risk for major cardiovascular events.
Additionally, it was shown to reduce cardiovascular morbidity by 22%, any morbidity by 15%, and advanced diabetic kidney disease by 22%. This could have a positive impact on the way clinicians and cardiologists interact with diabetes patients.
“The link between [cardiovascular disease (CV)] and diabetes is well established, and although advances in the management of CV risk factors have reduced the rate of CV events, residual CV remains a significant concern,” Novo
Nordisk told MD Magzine. “We support better communication between endocrinologists, primary care physicians, and cardiologists so that there is a shared focus on what can be done to address CV risk in patients living with diabetes.”
Normally, the FDA requires 2 clinical studies for a decision on a new indication, but in light of that, the agency noted in a statement that it can rely on one study when it's shown “highly reliable and statistically strong evidence of an important clinical benefit, such as an effect on survival, and a confirmatory study would have been difficult to conduct on ethical grounds.”
Approval would allow for the addition to the drug’s label, which Novo Nordisk said would “provide important guidance to prescribers considering their options to treat” patients with type 2 diabetes.
There was a concern of the drug’s performance in subgroups, which lead to the 2 “no” votes it received from the panel. Carmen J. Allegra, MD, chief of hematology and oncology at the University of Florida, noted that the analysis of the subgroup “concerned and swayed” him to his vote.
The FDA previously approved liraglutide in Jan. 2010 for the treatment of adults with type 2 diabetes, and under another brand name, Saxenda, for obesity treatment. It will remain that way regardless of the decision, too. Novo Nordisk told MD Magazine that it is “continuing to study liraglutide in patients with diabetes as well as other conditions, such as obesity.”
Liraglutide’s performance in reducing major adverse cardiovascular events (MACE) is a positive sign for the potential decision from the FDA. Previously, the FDA approved empagliflozin (Jardiance, Boehringer Ingelheim Pharmaceuticals) for the treatment of cardiovascular morbidity risk in adults with type 2 diabetes.
Whether or not liraglutide is approved, Novo Nordisk said, it “will continue to be available to physicians as an important treatment option for people living with type 2 diabetes who are not yet at goal.”