The U.S. Food and Drug Administration approved Novo Nordisk’s (NYSE:NOV) weight-loss medication Wegovy on Friday for mitigating the risk of stroke and heart attack in overweight or obese adults without diabetes.
Novo’s widely used diabetes drug Ozempic and the weight-loss drug Wegovy, scientifically known as semaglutide, fall under the category of GLP-1 agonists. Initially developed for type 2 diabetes, these drugs also curb food cravings and slow down stomach emptying.
John Sharretts, FDA’s director of the Division of Diabetes, Lipid Disorders, and Obesity, emphasized the heightened cardiovascular risks faced by obese or overweight individuals. He hailed the approval of a treatment proven to lower such risks as a significant advancement in public health.
While millions already use Novo’s GLP-1 drugs, the FDA’s endorsement of their heart benefits is expected to expand their utilization to a broader patient base.
Dr. Chad Weldy from Stanford University highlighted the evolving role of cardiology groups in incorporating these therapies into clinical practice, stressing the need for monitoring dose escalation, side effects, and insurance approval.
The FDA recommends healthcare practitioners closely monitor patients for kidney disease, diabetic retinopathy, depression, or suicidal behaviors or thoughts while on this medication.
Novo Nordisk released comprehensive data in November from a substantial clinical trial demonstrating Wegovy’s ability to reduce the risk of non-fatal heart attacks by 28%, non-fatal strokes by 7%, and heart-related deaths by 15% compared to a placebo in patients with pre-existing heart conditions.
In the trial involving 17,604 patients over an average duration of 33 months, researchers observed the protective cardiovascular effects soon after initiating treatment, suggesting benefits beyond mere weight loss.
The FDA’s approval of Wegovy’s cardiovascular indications might encourage employers and insurers to cover the drug despite its high cost, currently priced at $1,349 for a month’s supply.
Dr. A. Michael Lincoff from the Cleveland Clinic, who led the Wegovy heart trial, expressed optimism that with FDA recognition, Wegovy could become as commonly prescribed as drugs for managing high cholesterol, blood pressure, and diabetes.
Novo Nordisk’s application to include Wegovy’s heart benefits in its European approval is pending review by the European Union’s drug regulator, with a decision expected later this year.
Following the FDA’s announcement, Novo Nordisk’s U.S.-listed shares experienced a 2% decline on Friday but rebounded by 1.2% to $134.71 in extended trading.
Wegovy, known to help patients shed an average of 15% of their weight after 68 weeks of treatment, initially gained FDA approval for obesity treatment in June 2021.
While some leading U.S. obesity experts anticipate Eli Lilly’s (NYSE:LLY) weight-loss drug Zepbound to yield similar heart benefits as Wegovy, Lilly plans to release data from a late-stage trial evaluating Zepbound’s efficacy in treating heart failure later this year.
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