The hottest drug class in the world just got even hotter after the FDA approved Novo Nordisk’s weight-loss drug Wegovy for cardiovascular event risk reduction, opening new cardiology-focused routes for GLP-1 care and coverage.
- Wegovy’s expanded FDA approval now supports its use for the reduction of major adverse cardiovascular events in obese or overweight adults with established CVD.
- Semeglutide was already approved for diabetes (via Ozempic) and weight loss (via Wegovy), although payors have largely resisted covering non-diabetic patients.
The expanded approval could have a major cardiology impact, making cardiologists a key driver of Wegovy prescriptions, while making CVD risk reduction a primary way to increase coverage of the GLP-1 (vs. out-of-pocket or on/off-label diabetes care).
More importantly, it could lead to significantly better cardiovascular outcomes for these patients. The SELECT trial, which served as the basis for this expanded CVD approval, showed that Wegovy slashed patients’ major cardiac event risks by 20% over five years, while cutting non-fatal heart attacks by 28% and reducing cardiovascular mortality by 15%.
- The SELECT trial included the types of patients who are most likely to be impacted by Wegovy’s expanded approval: non-diabetics with obesity and established CVD.
Considering that the overwhelming demand for GLP-1s gives Novo Nordisk little reason to reduce Wegovy’s $1,350 monthly price, the expanded coverage should further increase healthcare’s overall GLP-1 costs.
- However, this expansion could serve as a case study for whether GLP-1s’ ability to reduce future cardiovascular events makes both clinical and financial sense over the long term.
Wegovy’s CVD approval might also pave the way for similar expansions for Lilly’s tirzepatide (Mounjaro and Zepbound), which has shown even stronger weight loss results than semeglutide, and is now being evaluated for its cardiovascular benefits in clinical trials.
The Takeaway
To many people, Wegovy’s expanded FDA approval is an accessibility and affordability story, giving millions of patents a new route for GLP-1 care and coverage. However, this is also very much a cardiology story, as it could reduce those same millions of patients’ major cardiac events by 20%, while giving cardiologists a central role in managing a drug class that’s poised to dominate the next decade.
