The Food and Drug Administration announced Friday that it has cleared Novo Nordisk, the maker of Ozempic, to sell Wigovy, a weight-loss drug intended to benefit the heart. Novo Nordisk announced that a study of 17,000 patients showed that those who took Wigovy had a 20% lower risk of heart events compared to those who took a placebo. . File photo: Ida Marie Odgaard/EPA-EFE

“We recognize how important this moment is for the millions of people living with overweight, obesity and known heart disease, and we are committed to helping them,” Doug Langa, president of Novo Nordisk, said in a statement. We will continue to pursue options that put needs first.”

The label expansion is expected to improve insurance coverage for Novo Nordisk’s better-known Ozempic sister drug, Wigovy, which comes with out-of-pocket costs of more than $1,300 per month. Many insurance companies, including Medicare, do not cover weight loss medications.

Dr. Harlan Krumholtz, a cardiologist and scientist at Yale University and Yale-New Haven Hospital, said Wegovy’s emphasis is “on health, not appearance.”

“The evidence is that medicines reduce risk and save lives. It is therefore defensible to deny people access to, or make it difficult for people to access, medicines that directly improve their health. There is no room for that,” she said.

The FDA’s approval was based on a study of 17,000 patients that showed people who took Wegovy had a 20% lower risk of cardiac events than those who took a placebo.

Wegovy is indicated for people who are considered obese (BMI 30) or overweight (BMI 27) and have at least one “weight-related” disease, such as high blood pressure or cholesterol.

“This patient population is at high risk for cardiovascular death, heart attack, and stroke,” Dr. John Sharetz, director of the FDA’s Division of Diabetes, Dyslipidemia, and Obesity, said in a statement. “Providing treatment options that are proven to reduce this cardiovascular risk is a major advance for public health.”

According to the FDA, approximately 70% of American adults are obese or overweight. These conditions increase the risk of premature death and cardiovascular health problems.

Novo Nordisk’s trial was conducted in people who had had a previous cardiac event. Further research is needed to determine the cardiac benefits in people who have not experienced a cardiac event.

Although FDA approval could improve insurance coverage for Wegovy, drug shortages continue as manufacturers struggle to keep up with demand. Novo He said Nordisk would gradually increase supply during this year.

“The supply shortage is really, really severe right now,” Dr. Jodi Dusha, an endocrinologist at Beth Israel Deaconess Medical Center and an assistant professor at Harvard Medical School, told CNN.

Duchey said he hopes approval will improve insurance coverage because generic weight loss drugs come with increased heart risks, but expanded access could create demand that manufacturers can’t meet. Ta.

Langa said in a statement that Novo Nordisk is working to “increase manufacturing capacity to responsibly supply this important medicine.”