Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels.

The med is now the first weight loss treatment to score an FDA nod to reduce the risk of cardiovascular death, heart attack and stroke in adult patients with cardiovascular disease who have obesity or are overweight.

It’s a “major advance for public health” in a population with an elevated risk of severe cardiovascular outcomes, the FDA Center for Drug Evaluation and Research’s head of diabetes, lipid disorders and obesity, John Sharretts, M.D., said in the agency’s release.

The FDA based the approval on Novo’s SELECT cardiovascular outcomes trial, which tested Wegovy over five years in 17,604 patients who were obese or overweight with established cardiovascular disease and no history of diabetes.

Treatment with Wegovy cut the risk of major adverse cardiovascular events by 20% compared with placebo when added to standard-of-care blood pressure and cholesterol management as well as lifestyle efforts such as diet and physical activity.

The drug's benefits lasted up to five years regardless of baseline body mass index or level of renal function impairment. Wegovy was associated with a 15% risk reduction in cardiovascular death and a 19% reduction in the risk of death from “any cause,” Novo said in its press release.

The new nod might very well raise the stakes in the market battle between Novo’s offering and Eli Lilly’s competing offering Zepbound.

“The big competition in the GLP-1 space is the battle for best label,” former FDA Commissioner Scott Gotlieb, M.D., wrote in a social media post. “For a time, Wegovy is going to have the better label, even if Zepbound may be a better drug.”

The broader label might make insurers more inclined to cover Wegovy over Zepbound, meaning “we’re likely to see even more aggressive discounting from Lilly,” Gottlieb opined.

Still, Wegovy’s impact in heart health could be a bigger-picture win for “Lilly and the obesity category at large,” Wolfe Research’s Tim Anderson, M.D., wrote in a note to clients after Novo’s SELECT study readout, which came before Lilly had launched Zepbound as a follow-up to diabetes med Mounjaro.

As for Novo, blockbuster Wegovy and its other semaglutide-based products have been propelling the company's growth since Wegovy’s 2021 launch. Demand has been so strong that the meds have faced major supply issues. After previously pausing marketing efforts for Wegovy, the company relaunched the drug in January and has more than doubled its supply of starter doses, Chief Financial Officer Karsten Munk Knudsen said in a call with investors earlier this year.

Wegovy brought in a whopping $4.6 billion over 2023. The company’s obesity sales skyrocketed by 147% during the year, reflecting massive demand.

Novo filed for the same label expansion in Europe, with a decision slated for this year.