FDA approves label extension for GLP-1RA for CV risk reduction in overweight or obesity and established CVD


The FDA has approved a label extension in the US for semaglutide for the indication of reducing CV risk in adults with either overweight or obesity, and established CVD.

The approval is based on the recently presented SELECT CV outcomes trial, which showed that once weekly subcutaneous semaglutide 2.4 mg reduced the risk of the primary outcome of CV death, MI, or stroke by 20% in patients with pre-existing CVD and overweight or obesity, compared to placebo. Risk reductions in MACE were achieved regardless of sex, race, ethnicity, BMI, baseline age and level of renal function impairment.

Label extension has also been filed for in the EU and a decision is expected in 2024.

Source: Press release Novo Nordisk, March 8, 2024

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