FDA Approves Tirzepatide for Treating Obesity

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FDA Approves Tirzepatide for Treating Obesity

The US Food and Drug Administration (FDA) has approved tirzepatide for chronic weight management in adults with obesity or overweight.

Eli Lilly & Company will market tirzepatide injections for weight management under the trade name Zepbound. It was approved in May 2022 for treating type 2 diabetes. The new indication is for adults with either obesity, defined as a body mass index (BMI) of 30 kg/m2 or greater, or overweight, with a BMI 27 kg/m2 or greater with at least one weight-related comorbidity, including hypertension, type 2 diabetes, or dyslipidemia.

“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,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

A once-weekly injection, tirzepatide reduces appetite by activating two gut hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The dosage is increased over 4 to 20 weeks to achieve a weekly dose target of 5 mg, 10 mg, or 15 mg maximum.

Tirzepatide can cause gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and abdominal pain or discomfort. Site reactions, hypersensitivity, hair loss, burping, and gastrointestinal reflux disease have also been reported.

The medication should not be used by patients with a personal or family history of medullary thyroid cancer or by patients with multiple endocrine neoplasia syndrome type 2. It should also not be used in combination with Mounjaro or another GLP-1 receptor agonist. The safety and effectiveness of the coadministration of tirzepatide with other medications for weight management have not been established.

Zepbound should go to market in the US by year’s end, with an anticipated monthly list price of $1060, according to a news release from Eli Lilly.

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