Novo Wins EU Panel Approval for Wegovy in Cardiovascular Treatment

On August 12, 2023, Novo Nordisk, a leading Danish pharmaceutical company headquartered in Copenhagen, received a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP). This opinion pertains to an update of the labeling for Novo Nordisk’s weight-loss medication, Wegovy (semaglutide), to highlight its cardiovascular benefits. This recommendation from the European Medicines Agency (EMA) marks a significant advancement for the drug.

The proposed label update emerges from findings in the STEP HFpEF and STEP HFpEF-DM studies. These studies indicated that Wegovy significantly alleviates symptoms associated with heart failure in patients who have obesity-related heart failure with preserved ejection fraction (HFpEF), regardless of whether they have type 2 diabetes. Moreover, the trials revealed that Wegovy enhances physical capabilities and exercise performance in these patients.

Martin Holst Lange, Novo Nordisk’s head of development, emphasized the importance of this update. He noted that this endorsement represents a crucial step for patients grappling with obesity-related HFpEF, who currently face limited treatment options. Lange highlighted that Wegovy not only improves the health-related quality of life for these individuals but also enables them to engage more fully in daily activities.

The CHMP’s positive opinion is a crucial step that will assist the European Commission (EC) in making its final decision regarding the label update. Novo Nordisk expressed optimism about the outcome, anticipating that the EU label update will be implemented soon.

Earlier, in July 2024, the CHMP had also supported an update to Wegovy’s label based on data from the SELECT study. This late-stage trial demonstrated that Novo Nordisk’s GLP-1 therapy, in conjunction with standard care, could reduce the risk of major adverse cardiovascular events (MACE) by 20% in adults with existing cardiovascular disease. MACE encompasses cardiovascular death, non-fatal heart attack, and non-fatal stroke.

At the time, Lange described the recognition from the CHMP as a "significant milestone" for patients, underscoring Wegovy's potential in reducing the risk of major cardiovascular events and thus saving lives.

In March 2024, semaglutide, marketed by Novo Nordisk as Wegovy, received approval from the U.S. Food and Drug Administration (FDA) to lower the risk of cardiovascular death, heart attack, and stroke in adults who are obese or overweight and have cardiovascular disease.

Supporting the cardiovascular benefits of Wegovy and GLP-1 receptor agonists, the research firm Dandelion Health released a report earlier this week. Utilizing real-world clinical data and an AI-powered analytic algorithm, Dandelion concluded that GLP-1 treatments could serve as a "primary prevention" measure against MACE in patients who are otherwise asymptomatic.

Dandelion’s analysis suggested that GLP-1 therapies could reduce the risk of MACE by 15% to 25%. According to the firm, this reduction can be extended to primary prevention, potentially benefitting around 44 million patients with early intervention. The report estimated that GLP-1 treatments could prevent up to 17,300 heart attacks and 16,700 strokes annually in the United States.

This series of endorsements and findings highlight the growing recognition of Wegovy’s therapeutic benefits, extending beyond weight loss to significant cardiovascular improvements, thereby offering hope to millions of patients worldwide.