Eli Lilly weight loss drug Zepbound approved by the FDA

Move over, Ozempic — there’s a new drug in town.

Eli Lilly’s Zepbound, with the active ingredient tirzepatide, has been approved by the Food and Drug Administration for use by obese or overweight adults who have at least one weight-related health complication, like Type 2 diabetes, high blood pressure or high cholesterol.

Tirzepatide, sold as Mounjaro, has already been approved for treating Type 2 diabetes since May 2022, but now, patients can be prescribed the drug for chronic weight management.

“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” Dr. John Sharretts, the director of the Division of Diabetes, Lipid Disorders and Obesity for the FDA’s Center for Drug Evaluation and Research, said in a statement.

“In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.” 

Approximately 70% of Americans are overweight or obese, according to the FDA, and a worrying report published by the World Obesity Federation this year projected that more than half of the world’s population could be overweight or obese by 2035.

However, the FDA reports that dropping only 5% to 10% of overall body weight can lower the risk of developing heart disease as a result — cue weight management drugs, which can help people lose stubborn pounds when diet and exercise alone fail.

“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice – something that people should manage themselves,” Dr. Leonard Glass, the senior vice president global medical affairs at Lilly Diabetes and Obesity, said in a statement.

“Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”

Zepbound, which was approved Wednesday, has been shown to be an effective chronic weight management drug in combination with lifestyle changes like diet and exercise by activating the receptors for two hormones — glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide — to suppress appetite, thereby curbing food intake.

Side effects of the weekly injectable include nausea, vomiting, abdominal discomfort or pain, fatigue, diarrhea, constipation, burping, hair loss, acid reflux and allergic reactions.

In trials, the drug caused thyroid C-cell tumors in rodents, although it is unknown whether Zepbound can result in the same cancer in humans.

According to the drug’s manufacturer, Zepbound is expected to be available to Americans by the end of the year for a list price of approximately $1,059, which Eli Lilly estimates is 20% less than rival semaglutide, otherwise known as Novo Nordisk’s Ozempic or Wegovy, which costs a staggering $1,300.

But the demand for a weight loss cure-all soars has led to a market of dangerous counterfeit dupes, which have landed desperate users in the hospital.

And, despite the pressure for more medication access, “it does not improve or change insurance coverage,” which has been limited, explained Dr. Angela Fitch, the chief medical officer at weight-inclusive healthcare company Knownwell.

“It remains a problem that obesity is treated as a carve out condition instead of a standard benefit, despite the fact that it is a chronic condition,” she told The Post in a statement.

“We’re hopeful that with continued advocacy,  advancement in science, and data, we will continue to see improved access to this life-changing medication.”