NOVO Nordisk's weight-loss drug Wegovy (semaglutide) was approved by the US Food and Drug Administration (FDA) on Fri for new implications of lowering the risk of stroke and heart attack in overweight or obese adults who do not have diabetes, Reuters has reported.
Novo's semaglutide belongs to a class of drugs called GLP-1 agonists and is taken by millions of people already, but the FDA's stamp of approval for the heart benefits is likely to open its use to more patients worldwide.
The new drug approval comes after a large clinical trial was published by the Danish drug maker in Nov.
The study found that 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 was seen almost immediately after commencing 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 will provide employers and insurers more reason to cover the drug despite its high cost.
First approved by the FDA to treat obesity in Jun 2021, Wegovy's list price is US$1,349 (A$2,039) for a month's worth of injections for patients and is in high demand as it has demonstrated that people lose an average of 15% of their weight after 68 weeks of treatment.
Further, several US obesity specialists have stated they expect Eli Lilly's rival weight-loss drug Zepbound could produce the same or similar heart benefits as Wegovy because both belong to the same class of medicine.
Lilly expects to publish data from its late-stage clinical trial testing Zepbound as treatment for heart failure later this year. JG
The above article was sent to subscribers in Pharmacy Daily's issue from 13 Mar 24
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 13 Mar 24
