Eli Lilly’s Zepbound (tirzepatide) has received approval from the US Food and Drug Administration (FDA) for the treatment of overweight or obese adults with weight-related medical problems.
The drug also received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for weight loss and weight management.
Zepbound is an incretin hormone receptor agonist that targets glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. It has previously been approved by the FDA for the treatment of type 2 diabetes and is sold as Mounjaro.
Weight loss management is a growing market, with Novo Nordisk being the market leader in the field. The company’s weight loss drugs, Wegovy (semaglutide) and Saxenda (liraglutide), generated Dkr30.4bn ($4.36bn) in combined global sales in the first nine months of 2023, as per Novo Nordisk’s Q3 financials.
Lilly has set Zepbound’s list price in the US at $1,059.87, approximately 20% less than that for Wegovy, which has a list price of $1,349.02, as per an 8 November press release. Lilly plans to launch the drug in the US in six doses, ranging from 2.5mg to 15mg, by the end of this year.
Zepbound’s FDA approval was based on the results from the Phase III SURMOUNT-1 and SURMOUNT-2 trials. The 2,539 participants evaluated in the SURMOUNT-1 trial (NCT04184622) demonstrated average weight loss of 34lb and 48lb with 5mg and 15mg of Zepbound, respectively.
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Zepbound is indicated for use in addition to a reduced-calorie diet and increased physical activity. The drug use is cautioned in patients with a history of pancreatitis, or with severe gastrointestinal disease, and for use in conjunction with other tripeptide-containing or GLP-1 receptor agonist drugs.
Zepbound carries a boxed warning for thyroid C-cell tumours. The drug is contraindicated in adults with a personal or family history of medullary thyroid carcinoma, in patients with multiple endocrine neoplasia syndrome type 2, and in adults with known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound, as per an 8 November press release.