Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack in some patients.
Perhaps even more importantly, Novo said this weekend in Philadelphia at the American Heart Association (AHA) Scientific Sessions that the cardiovascular benefits gained from Wegovy aren’t due solely to weight loss.
The phase 3 SELECT trial showed that use of Wegovy versus placebo lowered the risk of a non-fatal heart attack by 28% and the risk of progression of chronic kidney disease and renal death by 22%.
Additionally in the study—which included nondiabetic obese and overweight patients with established cardiovascular disease—Wegovy was found to reduce the risk of heart-related death by 15% and the risk of death by any cause by 19%. It also cut the risk of developing diabetes by 73% and the risk of non-fatal stroke by 7%.
Novo also pointed out that the reduction of major adverse cardiovascular events (MACE) was evident soon after the initiation of treatment “suggesting an effect that is more rapid than what would be expected if the cardiovascular effects were entirely mediated with the effects of (Wegovy) on body weight reduction.”
The trial, which began in 2018 and enrolled 17,604 patients in 41 countries, is the largest ever conducted by the company. Patients were at least 45 years old and had a BMI of 27 or higher. Mean duration of exposure to Wegovy was 33 months, “providing greater perspective on real-world, long-term expectations of Wegovy,” analysts at Leerink wrote.
“The data demonstrate consistent benefit in cardiovascular outcomes regardless of baseline characteristics including BMI, age, HbA1c (blood glucose level) and eGFR (kidney function),” Leerink added in its note to investors. “Extraordinary health benefits, in our view.”
The results could keep Novo a step ahead in its battle with Eli Lilly to combat obesity, “justifying a change in patient care,” analysts at ODDO BHF wrote. They added that there is “differentiation compared with Zepbound,” referring to Lilly’s newly approved answer to Wegovy.
Results from clinical trials suggest that Lilly’s tirzepatide treatments Zepbound (in weight loss) and Mounjaro (in diabetes) can produce superior weight loss to Novo’s semaglutide drugs, which includes Wegovy, and diabetes meds Ozempic and Rybelsus.
Earlier this fall, Novo filed for a label update of Wegovy in the United States and Europe to include its heart benefits. The company added that it expects those decisions to be made in 2024.
Gaining those expansions will help increase insurance coverage for nondiabetic patients with cardiovascular disease, William Blair and Leerink said.
Andy Hsieh, an analyst William Blair, pointed out that the Medicare Prescription Drug Improvement and Modernization Act of 2003, prohibits Medicare Part D plans from covering weight loss management drugs and new legislation would be required before Wegovy can be reimbursed.
Wegovy is already a standout seller for Novo, now making more than $1 billion a quarter, although there have been limits on supply given the huge demand for the drug.