FDA OKs Cardiovascular Risk Reduction Indication for Semaglutide

Officials with the FDA have approved a new indication for Novo Nordisk’s semaglutide (Ozempic) injection 0.5 mg or 1 mg, according to a press release.¹

The new indication expands semaglutide’s use to reduce the risk of major adverse cardiovascular events (MACE), such as heart attack, stroke, or death, in adults with type 2 diabetes and established cardiovascular disease (CVD).¹

Additionally, the prescribing information for semaglutide tablets (Rybelsus) has been updated to include an analysis from the primary endpoint of the PIONEER 6 CVOT, showing the hazard ratio for time to first 3-component MACE (HR 0.79 [95% CI: 0.57, 1.11]).¹

Semaglutide, a once-weekly, glucagon-like peptide receptor agonist, was initially approved by the FDA in 2017, for use along with diet and exercise to improve blood sugar in adults with type 2 diabetes.

The approval of its CV indication is based on data from the SUSTAIN 6 cardiovascular outcomes trial (CVOT), which examined CV safety with the addition of semaglutide or placebo to standard of care in 3297 adults with type 2 diabetes and established CVD over a 2-year period.²

According to the results, semaglutide significantly reduced the risk of the occurrence of a 3-component MACE endpoint consisting of CV death, non-fatal heart attack, or non-fatal stroke. Overall, the estimated relative risk reduction of MACE in patients treated with semaglutide was 26% versus placebo (HR 0.74 [95% CI: 0.58, 0.95], p<0.001 for noninferiority, median observation time 2.1 years). The primary composite outcome occurred in 6.6% of patients treated with semaglutide versus 8.9% in placebo-treated patients. Non-fatal heart attack occurred in 2.9% of patients receiving semaglutide and in 3.9% of those receiving placebo (HR, 0.74; 95% CI, 0.5 to 1.08; P=0.12), and non-fatal stroke occurred in 1.6% and 2.7%, respectively (HR, 0.61; 95% CI, 0.38 to 0.99; P=0.04), according to the study.²

In terms of safety, patients treated with semaglutide experienced gastrointestinal adverse events (AEs) more frequently than those treated with placebo, with the majority of these AEs occurring within the first 30 weeks.²

“There is a well-established link between cardiovascular disease and type 2 diabetes. It’s one of our biggest concerns with type 2 diabetes because even when patients reach their blood sugar targets, the risk of a major adverse CV event remains,” Todd Hobbs, vice president and US chief medical officer of Novo Nordisk, said in a statement.¹ “Today’s milestone establishes Ozempic as an option for patients to help address 2 critical aspects of managing type 2 diabetes, blood sugar control, and cardiovascular risk reduction, in those with known heart disease.”

References:

• FDA approves Ozempic for cardiovascular risk reduction in adults with type 2 diabetes and known heart disease, updates Rybelsus label [news release]. Novo Nordisk’s website. https://www.novonordisk-us.com/media/news-releases.html?122981. Accessed January 17, 2020.

• Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. New England Journal of Medicine. 2016. DOI: 10.1056/NEJMoa1607141