The US Food and Drug Administration (FDA) has approved a label update for Novo Nordisk’s glucagon-like peptide-1 receptor agonist (GLP-1RA) injectable weight loss therapy Wegovy (semaglutide) for the reduction in the risk of cardiovascular (CV) death, heart attack, and stroke in adults with heart disease who are diagnosed as obese or overweight. This label expansion adds to Wegovy’s current prescribing label for adults and children aged 12 years and older with obesity, which makes Wegovy the first weight-loss medication that has been approved to reduce the risk of CV events in adults with CV disease and obesity or are overweight.

Wegovy has increasingly gone from strength to strength in terms of market share in the obesity space, and Novo Nordisk has achieved significant growth in its market cap from its success in the GLP-1 space with Wegovy, Ozempic, and Rybelsus, with the last two primarily prescribed for type 2 diabetes (T2D). As a result of the demand for Wegovy, due to its unprecedented results in treating obesity, Novo Nordisk has had significant challenges in maintaining the supply of the drug and the company is expanding its manufacturing capacity with the recent acquisition of Catalent. Key opinion leaders (KOLs) interviewed by GlobalData have previously reported they would like to see therapies with expanded labels that cover several cardio-metabolic conditions that increase the risk of (and are comorbidities of) T2D, and these therapies will likely gain significant market uptake.

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Results from the Phase III SELECT trial demonstrated a 20% risk reduction in major CV events, and the risk of death from CV causes was 15% lower in patients who received the therapy. The study enrolled 17,604 patients, one of the largest studies investigating GLP-1 in adults to date, with the major adverse cardiovascular events (MACEs) examined including CV death, non-fatal myocardial infarction, and non-fatal stroke. Wegovy significantly reduced the risk for the first occurrence of a three-part composite MACE endpoint of CV death, non-fatal myocardial infarction, and non-fatal stroke. The primary composite outcome occurred in 6.5% of patients who were treated with Wegovy and in 8.0% of the placebo group. The relative risk reduction of MACE was 20% vs. placebo (HR 0.80 [95% CI: 0.72, 0.90] p<0.001, absolute risk reduction of 1.5% at 40 months, the mean follow-up duration). The proportion of patients reported to have serious adverse events was reported to 33.4% of patients randomised to Wegovy 2.4mg and 36.4% of patients receiving placebo, with gastrointestinal disorders being the most common adverse event leading to discontinuation, occurring in 10% of patients in the Wegovy group and 2% in the placebo group.

This approval makes Wegovy the first FDA-approved treatment that lowers weight and reduces the likelihood of MACE; Wegovy will likely gain even more uptake by patients and physicians in the US market, where it is already the leading obesity therapy. Novo Nordisk will likely continue to be the leader in the GLP-1 and obesity market for the near future, although Eli Lilly’s continued pursuits of label expansion for its dual-incretin agonist Mounjaro (tirzepatide) is likely to prove highly competitive. GlobalData predicts that Wegovy’s recent FDA approval will increase its market uptake and, as a result, continue to challenge the manufacturing capacity for the drug.