Eli Lilly’s Tirzepatide Receives FDA Approval for Obesity Treatment Under Brand Zepbound

November 8, 2023

Eli Lilly’s drug tirzepatide, branded as Mounjaro for type 2 diabetes, has gained FDA approval to treat obesity under the name Zepbound. This approval marks a significant development for Lilly and brings competition to Novo Nordisk’s Wegovy, which faces supply shortages. Zepbound targets GLP-1 and GIP hormones and has demonstrated up to 21% weight loss in trials, compared to Wegovy’s 15%. Both drugs, however, have side effects like nausea and carry a risk of thyroid C-cell tumors.

The approval comes as the demand for GLP-1-based obesity treatments surges in the U.S., where a large portion of the population could benefit from such medications. Insurers have been limiting access due to the high cost and indefinite treatment duration. Zepbound will be priced at $1,059.87 per month, with Lilly offering a savings card for those with commercial insurance.

Lilly plans to double its manufacturing capacity by year’s end to meet the expected demand and anticipates Zepbound’s availability in American pharmacies post-Thanksgiving. In the U.K., Mounjaro’s authorization has expanded to include obesity, with availability pending reimbursement negotiations.

Previously, Mounjaro was prescribed off-label for obesity, but insurers are now restricting this practice. The new obesity indication for Zepbound offers an alternative treatment option. With Lilly’s market value soaring due to Mounjaro’s success, Zepbound could give Lilly an advantage in the burgeoning obesity treatment market, potentially worth $100 billion.

While Novo boasts longer-term safety data for Wegovy, Lilly is conducting a similar study for Zepbound, which is expected to conclude in 2027. The presence of more approved drugs allows for personalized obesity treatments, with ongoing research to determine which patients respond best to specific medications. Despite the expansion in treatment options, supply challenges still need to be addressed due to the high demand for these effective therapies.

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[Source: STAT, November 8th, 2023]

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