Novo Nordisk’s Wegovy, a weight reduction drug presently in sizzling demand, now has information from a big, multi-year scientific trial displaying the product additionally reduces the danger of main coronary heart problems. The outcomes help use of the drug in a wider swath of sufferers, and Novo Nordisk mentioned it plans to hunt regulatory approvals to develop the drug’s label.
The double-blind, placebo-controlled examine enrolled 17,604 adults age 45 or older who had been categorized as obese or overweight. These contributors additionally had heart problems however no prior historical past of diabetes. The examine adopted contributors for as much as 5 years.
Novo Nordisk mentioned Tuesday that therapy with its once-weekly injectable drug, alongside commonplace of care, led to a 20% discount in main cardiovascular occasions (MACE), a composite consequence that encompasses cardiovascular demise, nonfatal coronary heart assault, and nonfatal stroke. Novo Nordisk’s preliminary information didn’t break down the precise particulars for every of these elements, however the firm mentioned all three contributed to the statistically superior discount in MACE threat in comparison with placebo.
Semaglutide, the principle pharmaceutical ingredient in Wegovy, belongs to a category of medicine known as GLP-1 agonists. Novo Nordisk’s kind 2 diabetes drug Ozempic is semaglutide, however in a decrease dose than Wegovy. These peptide medicine activate a receptor to extend ranges of insulin within the blood. GLP-1 agonists had been initially developed for treating sufferers with kind 2 diabetes however scientific testing in that indication additionally confirmed weight reduction, main Novo Nordisk and different firms to check these medicine particularly in weight reduction. Eli Lilly’s Mounjaro, accredited final 12 months for treating kind 2 diabetes, is presently underneath FDA assessment to be used in power weight administration.
GLP-1 medicine are dear with Wegovy carrying a price ticket of $1,300 for a field of 4 injectable pens. Medicare doesn’t but cowl these medicine; just a few insurance coverage firms do. A latest KFF survey discovered that simply 16% of respondents are all for taking weight-loss medicine if they aren’t lined by insurance coverage. With cardiovascular issues persevering with to be a significant driver of healthcare prices, information displaying GLP-1 medicine scale back cardiovascular dangers might assist persuade payers to cowl these merchandise.
Novo Nordisk’s newest scientific trial outcomes for Wegovy construct on prior cardiovascular outcomes information from exams of the drug in sufferers with kind 2 diabetes who’ve excessive cardiovascular dangers. In a examine enrolling 3,297 such sufferers, outcomes confirmed that therapy with Wegovy led to considerably decrease charges of cardiovascular demise, nonfatal coronary heart assault, and nonfatal stroke. The Novo Nordisk-sponsored examine adopted contributors for a median of two.1 years. It was not powered to point out superiority. The examine outcomes had been revealed in 2016 in The New England Journal of Drugs.
With outcomes from Wegovy within the bigger and longer examine named SELECT, Novo Nordisk contends it has information to help use of the drug as a brand new instrument towards heart problems. The corporate mentioned it plans to file regulatory submissions within the U.S. and Europe later this 12 months.
“Individuals residing with weight problems have an elevated threat of heart problems however to this point, there are not any accredited weight administration drugs confirmed to ship efficient weight administration whereas additionally decreasing the danger of coronary heart assault, stroke or cardiovascular demise,” Martin Holst Lange, government vice chairman for growth at Novo Nordisk mentioned in a ready assertion. “Due to this fact, we’re very excited in regards to the outcomes from SELECT displaying that semaglutide 2.4 mg reduces the danger of cardiovascular occasions. SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to alter how weight problems is regarded and handled.”
Picture: BrianAJackson, Getty Photos
