FDA News

FDA approves CV risk indication for semaglutide

The FDA on Thursday approved a new indication for the GLP-1 receptor agonist semaglutide to reduce the risk for major adverse cardiovascular events in adults with type 2 diabetes with known cardiovascular disease, according to a press release from Novo Nordisk.

The agency’s decision applies to semaglutide injection 0.5 mg or 1 mg (Ozempic) and is based on findings from the 2-year SUSTAIN 6 CV outcomes trial. As Healio previously reported, semaglutide reduced the risk for occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke among adults with type 2 diabetes at high CV risk. The estimated relative risk reduction for a major adverse CV event was 26% compared with placebo, for an HR of 0.74 (95% CI, 0.58-0.95). The primary composite outcome occurred among 6.6% of participants assigned semaglutide vs. 8.9% assigned placebo.

"There is a well-established link between cardiovascular disease and type 2 diabetes,” Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk, said in the release. “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. Today's milestone establishes Ozempic as an option for patients to help address two critical aspects of managing type 2 diabetes, blood sugar control and cardiovascular risk reduction, in those with known heart disease."

The FDA also approved updated prescribing information for oral semaglutide 7 mg and 14 mg (Rybelsus) to include information from the primary analysis for PIONEER 6. In that study, the HR for time to first occurrence of a three-component CV endpoint was 0.79 compared with placebo (95% CI, 0.57-1.11).

In June, Novo Nordisk initiated the SOUL CV outcomes trial with 9,642 adults with type 2 diabetes and established CVD, to further evaluate the CV effect of oral semaglutide, according to the release. The trial is investigating the effects of oral semaglutide on the incidence of major adverse cardiovascular events vs. placebo in addition to standard of care.

Disclosure: Hobbs is vice president and U.S. chief medical officer of Novo Nordisk.

The FDA on Thursday approved a new indication for the GLP-1 receptor agonist semaglutide to reduce the risk for major adverse cardiovascular events in adults with type 2 diabetes with known cardiovascular disease, according to a press release from Novo Nordisk.

The agency’s decision applies to semaglutide injection 0.5 mg or 1 mg (Ozempic) and is based on findings from the 2-year SUSTAIN 6 CV outcomes trial. As Healio previously reported, semaglutide reduced the risk for occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke among adults with type 2 diabetes at high CV risk. The estimated relative risk reduction for a major adverse CV event was 26% compared with placebo, for an HR of 0.74 (95% CI, 0.58-0.95). The primary composite outcome occurred among 6.6% of participants assigned semaglutide vs. 8.9% assigned placebo.

"There is a well-established link between cardiovascular disease and type 2 diabetes,” Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk, said in the release. “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. Today's milestone establishes Ozempic as an option for patients to help address two critical aspects of managing type 2 diabetes, blood sugar control and cardiovascular risk reduction, in those with known heart disease."

The FDA also approved updated prescribing information for oral semaglutide 7 mg and 14 mg (Rybelsus) to include information from the primary analysis for PIONEER 6. In that study, the HR for time to first occurrence of a three-component CV endpoint was 0.79 compared with placebo (95% CI, 0.57-1.11).

In June, Novo Nordisk initiated the SOUL CV outcomes trial with 9,642 adults with type 2 diabetes and established CVD, to further evaluate the CV effect of oral semaglutide, according to the release. The trial is investigating the effects of oral semaglutide on the incidence of major adverse cardiovascular events vs. placebo in addition to standard of care.

Disclosure: Hobbs is vice president and U.S. chief medical officer of Novo Nordisk.