By Patrick Wingrove and Sriparna Roy
(Reuters) -The U.S. Food and Drug Administration approved Novo Nordisk's weight-loss drug Wegovy on Friday for lowering the risk of stroke and heart attack in overweight or obese adults who do not have diabetes.
Novo's widely used diabetes drug Ozempic and weight-loss drug Wegovy, both chemically known as semaglutide, belong to a class of drugs called GLP-1 agonists. Originally developed for type 2 diabetes, they also reduce food cravings and cause the stomach to empty more slowly.
Patients who are obese or overweight are at "a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health," said John Sharretts, FDA's director of the Division of Diabetes, Lipid Disorders, and Obesity.
Millions of people already take Novo's GLP-1 drugs, but the FDA's stamp of approval for the heart benefits is likely to open their use to more patients.
Dr. Chad Weldy, a cardiologist at Stanford University, said he typically deferred to the primary care team to initiate and monitor therapy with drugs like Wegovy in the past, but said that likely is going to need to change.
"Cardiology groups will need to fully incorporate these therapies into clinic and build a clinical workflow to manage dose escalation, side effects, and insurance approval," he said.
Healthcare professionals should monitor patients taking the medicine for kidney disease, diabetic retinopathy and depression or suicidal behaviors or thoughts, the FDA said.
The Danish drugmaker published the full data in November from a large clinical trial that showed the obesity drug reduced the risk of non-fatal heart attack by 28%, non-fatal stroke by 7% and heart-related death by 15%, compared with a placebo, in patients with pre-existing heart conditions.
In the 17,604-patient trial with a mean duration of 33 months, the difference in heart protective benefits began to appear almost immediately after starting treatment in those who received Wegovy, researchers said, suggesting the positive impact was due to more than weight loss.
The FDA's approval of the new cardiovascular indications could give employers and insurers more reason to cover the drug despite its high cost. Wegovy carries a list price of $1,349 for a package with a month's worth of shots.
Health regulators can expand approved uses of medicines if new data shows them to be effective in other therapeutic areas after initial approval.
Dr A. Michael Lincoff of the Cleveland Clinic, who led the Wegovy heart trial, said with FDA recognition of the benefits, he hoped it would become as commonly prescribed as drugs for high cholesterol, blood pressure, and diabetes.
Novo's application for adding Wegovy's heart benefits to its European approval is currently under review by the European Union's drug regulator. It expects a decision this year.
U.S.-listed shares of Novo Nordisk closed down 2% on Friday but climbed 1.2% to $134.71 in extended trading.
Wegovy, which has been shown to help patients lose an average of 15% of their weight after 68 weeks of treatment, was first approved by the FDA to treat obesity in June 2021.
Some leading U.S. obesity specialists have said they expected Eli Lilly's rival weight-loss drug Zepbound would produce the same or similar heart benefits as Wegovy because both belonged to the same class of medicine.
Lilly expects to publish data from a late-stage trial testing Zepbound as a treatment for heart failure later this year.
(Reporting by Sriparna Roy in Bengaluru and Patrick Wingrove in New York; Editing by Bill Berkrot)
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