FDA approved a new indication for Wegovy (semaglutide 2.4 mg injection; Novo Nordisk) to improve exercise tolerance and quality of life in adults with heart failure with preserved ejection fraction (HFpEF) and obesity — based on the STEP-HFpEF and STEP-HFpEF DM trials. The label now supports use in patients with BMI ≥ 30 kg/m² or ≥ 27 kg/m² with obesity-related comorbidities and HFpEF.
On 10 September 2026, FDA approved a label expansion for Wegovy (semaglutide 2.4 mg injection; Novo Nordisk) ↗ to include a new indication: improvement of exercise tolerance and quality of life in adults with obesity-related heart failure with preserved ejection fraction (HFpEF), defined as BMI ≥ 30 kg/m² (or ≥ 27 with obesity-related comorbidities) plus an EF ≥ 45%. This is the first pharmacotherapy specifically approved for HFpEF beyond diuresis.
Evidence: STEP-HFpEF trials
The approval was supported by two randomised controlled trials. STEP-HFpEF enrolled patients with HFpEF and obesity without diabetes; STEP-HFpEF DM enrolled those with co-existing type 2 diabetes. Both trials showed statistically significant improvements in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) — a patient-reported quality-of-life measure — and in 6-minute walk test distance. Results were published in NEJM (STEP-HFpEF) ↗ and NEJM (STEP-HFpEF DM) ↗.
HFpEF: the unmet need
Heart failure with preserved ejection fraction (HFpEF) ↗ accounts for approximately 50% of all heart failure cases and disproportionately affects women and people with obesity. Unlike HFrEF, no prior therapy had demonstrated mortality benefit in HFpEF. Current guidelines recommend diuretics for symptom management; GLP-1 RAs now offer the first disease-modifying option for the obese HFpEF subgroup. See 2022 AHA/ACC Heart Failure Guidelines ↗.
Prescribing considerations
This indication is separate from Wegovy's weight-management and Ozempic's cardiovascular-risk-reduction indications. Semaglutide 2.4 mg is dosed by weekly subcutaneous injection with a dose-escalation schedule over 16–20 weeks. Common adverse effects include nausea, vomiting, diarrhoea, and constipation. Prescribers should review the updated DailyMed prescribing information ↗ and note the FDA patient/provider communication page ↗.
FAQ
What triggers an FDA label update?
Label updates can be triggered by post-market safety data from the FAERS database ↗, new clinical trial results, manufacturer-initiated reviews, or FDA-directed safety communications. The FDA can require label changes under 21 CFR 314.81 or negotiate them with manufacturers. See the FDA Safety-related Labeling Changes (SrLC) database ↗ for a full history.
Where is the updated label published?
Updated labels are published on DailyMed (NLM) ↗ and Drugs@FDA ↗. DailyMed is typically the most current source, as manufacturers submit label updates there directly.