INDIANAPOLIS: Eli Lilly and Company’s (NYSE: LLY) innovative obesity treatment, Zepbound™ (tirzepatide) injection, has received the green light from the U.S. Food and Drug Administration (FDA). This inventive solution, a first-of-its-kind therapy, targets both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound aims to assist adults struggling with obesity (BMI of 30 kg/m2 or higher) or those dealing with weight-related health issues such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease, in shedding weight and maintaining a healthy lifestyle.
“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,” said Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition. “New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management.”
The FDA’s decision was based on findings from the extensive phase 3 SURMOUNT-1 and SURMOUNT-2 trials. Participants in SURMOUNT-1, comprising 2,539 adults with obesity or weight-related medical problems (excluding diabetes), experienced noteworthy weight loss when using Zepbound in combination with diet and exercise, showcasing an average weight reduction of 48 lb. at the highest dosage and 34 lb. at the lowest dosage, compared to 7 lb. in the placebo group.
Notably, a substantial portion of patients administered the highest dose of Zepbound saw an impressive reduction of over 58 lb. (25% of their body weight), highlighting the potential of this treatment for significant weight management. Moreover, although not specifically intended for these conditions, participants noticed positive changes in cholesterol levels, blood pressure, and waist size while following a regimen of diet, exercise, and Zepbound treatment.
“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice – something that people should manage themselves,” said Dr. Leonard Glass, senior vice president global medical affairs, Lilly Diabetes and Obesity. “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.”
While presenting promising results, it’s imperative to note potential gastrointestinal side effects associated with Zepbound use. These include nausea, diarrhea, vomiting, constipation, and abdominal pain, among others. To ensure broader access to the treatment, Eli Lilly is introducing a commercial savings card program for eligible patients, offering reduced costs for prescriptions.
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Zepbound will launch in the U.S. market by the year-end, offering six different doses at a list price of $1,059.87, positioning it approximately 20% lower than the weight loss injection semaglutide 2.4 mg. The company is also awaiting regulatory approvals for Zepbound in other key global markets, including Europe, China, and the United Kingdom.
