The regulatory decision
On March 8, 2024, the FDA approved a new indication for Wegovy (semaglutide 2.4 mg) going beyond weight management: reducing the risk of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke in adults with obesity or overweight and established cardiovascular disease. It's the first time a GLP-1 has received that cardiovascular label for non-diabetics.
The SELECT trial
The SELECT trial, published in The New England Journal of Medicine in November 2023, randomized 17,604 patients to semaglutide 2.4 mg vs placebo over a median 33 months. Primary endpoint: 6.5% MACE in the semaglutide arm vs 8.0% in placebo — a 20% relative reduction (HR 0.80, 95% CI 0.72-0.90).
Coverage and market impact
Medicare, prohibited from covering 'weight loss' medication under the 2003 statute, can now cover Wegovy under the cardiovascular indication. CMS estimated up to 7 million eligible patients in the US alone. The impact for Novo Nordisk: up to $15 billion in additional annual peak sales, per JPMorgan.
Competitive ripples
Eli Lilly accelerated the SURMOUNT-MMO trial to chase the same indication with tirzepatide. Topline expected 2027. If Wegovy holds the cardiovascular claim alone for 3 years, it could lock in leadership against Lilly's gross weight-loss-efficacy edge.
Source: FDA press release
