INDIANAPOLIS — Officials with Eli Lilly and Company announced on Wednesday that its Zepbound™ (tirzepatide) injection has officially been approved by the U.S. Food and Drug Administration.
According to a news release from the company, the injection is an obesity treatment for adults, as well as for those who are overweight and have weight-related medical problems. Officials said the treatment activates both GIP, or glucose-dependent insulinotropic polypeptide, and GLP-1, or glucagon-like peptide-1, hormone receptors.
“Obesity is a chronic disease that can result in serious health complications, including heart disease, stroke and diabetes. Despite our knowledge of obesity as a treatable, chronic disease, people living with obesity still face many challenges in their health and weight management journey,” Joe Nadglowski, the president and chief executive officer of the Obesity Action Coalition, said in the release. “New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management.”
Officials said the approval came after a number of trials. More than 2,500 people who took the medication as an adjunct to diet and exercise experienced “substantial weight loss” compared with a placebo at 72 weeks. At the highest dose, people lost an average of 48 pounds, while at its lowest dose, people lost an average of 34 pounds.
“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice – something that people should manage themselves,” Leonard Glass, the senior vice president of global medical affairs for Lilly Diabetes and Obesity, said in the release. “For decades, diet and exercise have been a go-to, but it’s not uncommon for a person to have tried 20-30 times to lose weight with this approach. Research now shows that the body may respond to a calorie-deficit diet by increasing hunger and reducing feelings of fullness, making weight loss more difficult. Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”
The medication should be used with a reduced-calorie diet and increased physical activity, the release said. While not approved to treat these conditions, officials said people who dieted, exercised and too Zepbound also observed changes in cholesterol, as well as reductions in blood pressure and waist size.
“Far too many hurdles continue to prevent people living with obesity from accessing obesity treatments that could lead to significant weight loss,” Mike Mason, the executive vice president and president of Lilly Diabetes and Obesity, said in the release. “Broader access to these medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it.”
The release said that Zepbound is expected to be available in six doses by the end of the year at a list price of $1,059.87. Those who are commercially insured with coverage for the medication may be eligible to pay as low as $25 for a one month or three month prescription. Those who are insured but do not have coverage for Zepbound may be eligible to pay as low as $550 for a one month prescription of the medication.
The release said that tirzepatide is under regulatory review for weight management in Europe, China, the United Kingdom and other markets.