FDA greenlights Lilly’s Zepbound for obesity treatment

Eli Lilly’s blockbuster injectable GLP-1 (glucagon-like peptide 1 receptor agonist) drug has officially entered the obesity treatment market.

The FDA on Wednesday approved Zepbound (tirzepatide)—which is sold under Mounjaro as a Type 2 diabetes treatment—for chronic weight management in adults with obesity or body mass indexes (BMIs) of 30+ in addition to diet and exercise. The agency also approved Zepbound’s use in overweight adults with BMIs of at least 27 and who have at least one weight-related health condition, like high blood pressure or Type 2 diabetes.

With obesity affecting an estimated 42% of US adults, John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said the drug’s approval “addresses an unmet medical need.”

Zepbound is set to become available in the US in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) by the end of 2023 with a list price of approximately $1,060 for a one-month supply, Lilly executives said in a Wednesday release. The expected cost, they noted, is lower than the $1,349 list price for a 2.4 mg injection of Novo Nordisk’s Wegovy, a semaglutide that has also been approved for weight loss.

The approval comes just six months after the FDA greenlit Mounjaro for treatment of Type 2 diabetes.

Lilly executives further announced a commercial savings card program for Zepbound, which may allow some people with commercial insurance to pay as little as $25 for a one-month or three-month prescription. Meanwhile, patients with insurance that doesn’t cover the drug could be eligible to pay as little as $550 for a one-month prescription—about half the list price, the company noted.

Lilly Diabetes and Obesity EVP and President Mike Mason said “broader access to these medicines is critical” given the hurdles that prevent many people from getting treatment.

“Lilly is committed to working with healthcare, government, and industry partners to ensure people who may benefit from Zepbound can access it,” he said in a statement.

In clinical trials, patients taking the highest dose of Zepbound (15 mg) lost almost 50 pounds on average, while those taking the lowest dose (5 mg) lost about 34 pounds. Of those patients taking the highest dose, a third lost more than 58 pounds—or 25% of their body weight.

In recent years, the demand for GLP-1s has skyrocketed—a trend driven, in part, by growing “off-label,” or unapproved, use of the medications for weight management. That demand has sparked shortages of the drugs that were originally developed to treat Type 2 diabetes.

Despite the shortages, Lilly reported $1.41 billion in worldwide Mounjaro revenue in the third quarter of 2023, including $1.28 billion in the US alone. Company executives credited the drug with helping to drive a 37% increase in overall Q3 revenue.