The U.S. Food and Drug Administration (FDA) approved on Friday the first weight-loss drug for use to reduce the risks of life-threatening cardiovascular events in overweight or obese adults.
Drugmaker Novo Nordisk said that it received FDA approval to update the labeling of its weight loss drug Wegovy stating that it can be used to reduce a patient’s risk of heart attack, stroke, and cardiovascular death.
Wegovy contains semaglutide, which belongs to a class of drugs called GLP-1 agonists. This drug has so far been only approved for treating obesity and diabetes.
The FDA’s approval was based on a double-blinded trial with over 17,600 participants, which found that Wegovy significantly reduced the risk of cardiovascular events by 20 percent compared to placebo.
The trial was a large, double-blind, placebo-controlled study designed to assess the cardiovascular benefits of the drug in overweight and obese patients with preexisting heart disease but not diabetes.
Its findings showed that risk reductions in cardiovascular events were achieved over a five-year period regardless of baseline age, sex, race, ethnicity, body mass index, and level of renal function impairment.
Martin Holst Lange, executive vice president and head of Development at Novo Nordisk, said that the FDA’s approval marks “an important milestone” for people living with obesity and cardiovascular disease.
Heart Disease Among Leading Causes of Death Globally
Cardiovascular diseases are the leading cause of death worldwide, taking an estimated 17.9 million lives each year, according to the World Health Organization (WHO).WHO stated that more than four out of five cardiovascular-related deaths are due to heart attacks and strokes, and one-third of these deaths occur prematurely in people under the age of 70.
John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA, said that patients who are overweight or obese face “a higher risk of cardiovascular death, heart attack and stroke.”
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.
The prescribing information for Wegovy contains a boxed warning about the risk of thyroid C-cell tumors.
The FDA said that Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2.
Wegovy also contains warnings for inflammation of the pancreas, gallbladder problems, low blood sugar, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate and suicidal behavior or thinking, according to the FDA.
Wegovy, which has been shown to help patients lose an average of 15 percent 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 similar heart benefits as Wegovy because both belonged to the same class of medicine.
