FDA Approves Diabetes Drug Indication to Reduce CV Risk

Officials with the FDA have approved a new indication for liraglutide (Victoza, Novo Nordisk), making it the only type 2 diabetes drug indicated to reduce the risk of major adverse cardiovascular events in adults, according to a press release from Novo.

The approved indication is based on results from a clinical trial demonstrating that Victoza significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% compared to a placebo, when added to standard care.

The study, which included 9340 participants, investigated the long-term effects of the drug compared to a placebo, both in addition to standard of care, in individuals with type 2 diabetes at a high risk of cardiovascular events. Standard of care included lifestyle modifications, glucose-lowering treatments, and cardiovascular medications.

Victoza was initially approved by the FDA in 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes. The updated indication allows Victoza to be used to reduce the risk of major adverse cardiovascular events, such as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, in adults with type 2 diabetes and established cardiovascular disease.

Reference

Victoza approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of major adverse cardiovascular events [news release]. Denmark. Novo Nordisk’s website. https://www.novonordisk.com/media/news-details.2129162.html. Accessed August 25, 2017.