Introduction
Obesity-related heart failure with preserved ejection fraction (HFpEF) presents a significant health challenge, particularly in those with obesity and type 2 diabetes. Wegovy® (semaglutide 2.4 mg), a once-weekly subcutaneous injection, is now at the forefront of an important advancement. Recently, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending an update to Wegovy’s® label to reflect its efficacy in reducing symptoms of HFpEF and improving physical function in patients with obesity-related heart failure. This step could transform how obesity-related heart failure is managed, offering new hope for those living with limited treatment options.
Image Source: Vinoth Khandelwal
Current Regulatory Status
The CHMP’s recommendation is poised to result in a label update in the European Union (EU), following final approval by the European Medicines Agency (EMA). Novo Nordisk, the developer of Wegovy®, is also preparing to submit similar data to the U.S. Food and Drug Administration (FDA) in 2025, further expanding its global reach.
Drug Details and Mechanism of Action
Wegovy® is a glucagon-like peptide-1 (GLP-1) receptor agonist, already recognized for its effectiveness in weight management. Initially approved for weight reduction in individuals with a BMI of 30 kg/m² or greater, Wegovy® has also demonstrated potential to reduce cardiovascular risks. Now, with the CHMP’s positive opinion, its scope extends to HFpEF, an area in which obesity has been identified as a key contributor.
Clinical Trials and Key Findings
The STEP HFpEF and STEP HFpEF-DM trials form the backbone of this regulatory shift. Both trials explored the efficacy of Wegovy® in reducing heart failure symptoms and enhancing physical function, particularly in individuals with obesity and HFpEF, with or without type 2 diabetes. Results showed significant improvements compared to placebo, including reductions in heart failure-related symptoms and enhanced physical functionality, measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS). Importantly, participants in the Wegovy® groups also saw greater weight loss and improved exercise capacity, demonstrated by an increase in their 6-minute walking distance (6MWD).
Disease Context and Unmet Needs
HFpEF, which accounts for roughly half of all heart failure cases, is closely linked to obesity. Approximately 80% of individuals with HFpEF are overweight or obese, which exacerbates the symptoms of heart failure. Current treatment options are limited, leaving a large population of patients struggling with shortness of breath, reduced exercise capacity, and lower quality of life. Wegovy’s® dual impact on both weight management and heart failure symptomatology could represent a crucial intervention for this underserved patient group.
Conclusion
Wegovy® is on the verge of expanding its utility from a weight management drug to a multifaceted therapeutic solution for obesity-related heart failure. With the promising results from the STEP HFpEF trials, this development could address the unmet needs of those with HFpEF, a condition worsened by obesity. As regulatory processes progress in Europe and the U.S., Wegovy® may soon offer a lifeline to millions struggling with the dual burden of obesity and heart failure.
Dr. Vinoth Khandelwal, Ph.D.
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