Novo Nordisk, already popular weight loss med Wegovy, added another feather in its cap. NOVO’s SELECT cardiovascular outcome showed a 20% reduction in CV events. The study was conducted for five years on 17,604 patients who were obese or overweight. The trial was initiated in 2018. The FDA nod was based on the results of the above-mentioned clinical trial. Results of another 68-week clinical trial, which involved 1,961 adults with BMI ≥30 kg/m2 and obesity-associated problems like dyslipidemia or hypertension. Patients suffering from type 2 diabetes mellitus were excluded. Patients were categorized in 2:1 to either Wegovy (2.4 mg) or placebo. Participants were asked to have a calorie restriction diet of 500Kcal/day deficit and a minimum of 30 minutes of exercise per day for five days a week. The following primary and secondary endpoints were considered for drug efficacy (1):
- Mean percent change in body weight from baseline to week 68
- Change in waist circumference and systolic blood pressure from baseline to week 68
- Change in A1c, diastolic blood pressure, and lipid.
The trial results showed a 14.9% reduction in body weight compared to 2.4%. The study results suggested that most of the patients taking Wegovy reduced their body weight, ranging from 12-46 pounds, in a clinically meaningful way. The drug benefits are sustained for up to five years, irrespective of BMI or renal disease. Novo press release stated that star drug was able to reduce 15% of deaths caused by cardiovascular events and a 19% reduction in risk of death from any other cause. Novo has updated and expanded the label from the SELECT studies showing the above mortality-related data.
SELECT was a randomized, double-blind trial that was initiated to evaluate the efficacy of Wegovy (Semaglutide 2.4mg) Vs. placebo as an ancillary standard of care for the prevention of major adverse cardiovascular events (MACE). As mentioned above, only obese patients were included in the study who were having established cardiovascular diseases. The patients aged 45 years were included in the studies. The trial was conducted in 41 countries at more than 800 investigation sites. The results of the studies were presented at the American Heart Association (AHA) and were published in the prestigious New England Journal of Medicine (NEJM).
Novo updated the Wegovy label in the USA market. It now indicates that combined calorie restriction and increased physical activity reduced the risk of CVD. Wegovy helps reduce and maintain body weight. “The big competition in the GLP-1 space is the fight for the best label,” as mentioned by former FDA Commissioner Scott Gotlieb, M.D. Even though Zepbound from Lilly is a better drug, Wegovy has a better and expanded label. The broader label gives insurance companies coverage for Wegovy over Zepbound. Therefore, in the future, Lilly can offer more discounts on Zepbound. However, the mechanism underlying Wegovy CVD benefits remains unknown in these patients.
FDA Centre for Drug Evaluation and Research head John Sharretts, M.D., said that Wegovy made a major advance in public health. Currently, Novo is riding high on the success of its star drugs like Wegovy, and other glucagon-like peptide-1 (GLP-1) receptor agonists-based products are leading the company’s growth. The demand for the Wegovy is so strong that the company has faced shortage issues. To combat this problem, the company has paused drug marketing efforts. The company’s obesity sales increased by 147% during 2023 (2). Novo has filed for label expansion in Denmark, Norway, Germany, the U.K., Iceland, Switzerland, UAE, and Japan. Wegovy is a new superstar in the weight loss drug market.
Dr. Isha Sharma, Ph.D.
Reference:
- https://www.novomedlink.com/obesity/products/treatments/wegovy/efficacy-safety/clinical-trial-1-results.html
- Becker, Z. (2024, March 8). Novo’s obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion.
