Novo Nordisk logoSemaglutide was already one of the best-selling drugs of recent memory. And Novo Nordisk the fastest-growing Big Pharma firm. Now, the FDA’s decision to expand the label of its weight-loss version of the drug to include cardiovascular benefits could help unlock more growth momentum for Novo Nordisk. This positions Wegovy as the first weight-loss medication also cleared for reducing the risk of heart attack, stroke, or heart-related death in at-risk individuals. The approval, based on a 17,600-patient SELECT study demonstrating a 20% lower risk of cardiac events with Wegovy versus placebo, could have a material impact on sales. The study also found that patients lost an average of 15% of their weight.

The expanded FDA label sanctions the use of Wegovy for reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are obese or overweight. This marks a significant breakthrough in public health, offering an effective new treatment option for some of the most prevalent health challenges facing society today.

In the SELECT trial, Wegovy significantly outperformed placebo in reducing major adverse cardiovascular events. Additionally, Wegovy remains an approved treatment for long-term weight management in certain adults and children with obesity or overweight, used alongside a reduced-calorie diet and increased physical activity.

The development has generated significant interest among investors with analysts anticipating this label expansion will significantly impact Novo Nordisk’s sales. Over the past five days, its stock has jumped nearly 9% to $135.11 and 92.27% over the past year.

Recently, the company’s shares surged following the release of preliminary data highlighting Wegovy’s cardiovascular benefits. Potential barriers to adoption, however, include Wegovy’s substantial cost ($1,000 per month in the U.S.), which oculd limit access and reimbursement without legislative changes.

Despite potential cost hurdles, Wegovy’s strong market performance in 2023 ($4.6 billion in sales) and the expanded label, could be a harbinger of future growth.