Friday, September 22, 2023

Novo Nordisk’s Wegovy Posts Trial Data Supporting the Drug as Way to Lower Heart Risks – MedCity News

Novo Nordisk’s Wegovy, a weight loss drug currently in hot demand, now has data from a large, multi-year clinical trial showing the product also reduces the risk of major heart complications. The results support use of the drug in a wider swath of patients, and Novo Nordisk said it plans to seek regulatory approvals to expand the drug’s label.

The double-blind, placebo-controlled study enrolled 17,604 adults age 45 or older who were classified as overweight or obese. These participants also had cardiovascular disease but no prior history of diabetes. The study followed participants for up to five years.

Novo Nordisk said Tuesday that treatment with its once-weekly injectable drug, alongside standard of care, led to a 20% reduction in major cardiovascular events (MACE), a composite outcome that encompasses cardiovascular death, nonfatal heart attack, and nonfatal stroke. Novo Nordisk’s preliminary data did not break down the specific details for each of those components, but the company said all three contributed to the statistically superior reduction in MACE risk compared to placebo.

Semaglutide, the main pharmaceutical ingredient in Wegovy, belongs to a class of drugs called GLP-1 agonists. Novo Nordisk’s type 2 diabetes drug Ozempic is semaglutide, but in a lower dose than Wegovy. These peptide drugs activate a receptor to increase levels of insulin in the blood. GLP-1 agonists were initially developed for treating patients with type 2 diabetes but clinical testing in that indication also showed weight loss, leading Novo Nordisk and other companies to test these drugs specifically in weight loss. Eli Lilly’s Mounjaro, approved last year for treating type 2 diabetes, is currently under FDA review for use in chronic weight management.

GLP-1 drugs are pricey with Wegovy carrying a price tag of $1,300 for a box of four injectable pens. Medicare does not yet cover these drugs; only a few insurance companies do. A recent KFF survey found that just 16% of respondents are interested in taking weight-loss drugs if they are not covered by insurance. With cardiovascular problems continuing to be a major driver of healthcare costs, data showing GLP-1 drugs reduce cardiovascular risks could help persuade payers to cover these products.

Novo Nordisk’s latest clinical trial results for Wegovy build on prior cardiovascular outcomes data from tests of the drug in patients with type 2 diabetes who have high cardiovascular risks. In a study enrolling 3,297 such patients, results showed that treatment with Wegovy led to significantly lower rates of cardiovascular death, nonfatal heart attack, and nonfatal stroke. The Novo Nordisk-sponsored study followed participants for a median of 2.1 years. It was not powered to show superiority. The study results were published in 2016 in The New England Journal of Medicine.

With results from Wegovy in the larger and longer study named SELECT, Novo Nordisk contends it has data to support use of the drug as a new tool against cardiovascular disease. The company said it plans to file regulatory submissions in the U.S. and Europe later this year.

“People living with obesity have an increased risk of cardiovascular disease but to date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death,” Martin Holst Lange, executive vice president for development at Novo Nordisk said in a prepared statement. “Therefore, we are very excited about the results from SELECT showing that semaglutide 2.4 mg reduces the risk of cardiovascular events. SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”

Photo: BrianAJackson, Getty Images

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