Eli Lilly’s Zepbound Receives FDA Approval for Obesity Treatment

Eli Lilly’s tirzepatide, known as Mounjaro for treating type 2 diabetes, has received FDA approval to be used in treating obesity under the name Zepbound. This marks a significant milestone for Lilly and intensifies competition with Novo Nordisk, particularly as Novo Nordisk faces shortages in its obesity treatment, Wegovy. 

The FDA’s approval recognizes the increasing prevalence of obesity and addresses an unmet medical need. Both tirzepatide (Zepbound) and Novo Nordisk’s Wegovy target receptors of the GLP-1 hormone, with trials demonstrating substantial weight loss. Wegovy has shown a 15% reduction in body weight, while Zepbound, targeting both GLP-1 and GIP hormones, has demonstrated up to 21% weight loss. 

However, both medications share common side effects such as nausea, diarrhea, and vomiting, and they come with a boxed warning about the potential risk of thyroid C-cell tumours. The approval of Zepbound in the United States, expected to be available in pharmacies after Thanksgiving, could alleviate some of the demand challenges faced by Novo Nordisk.

Lilly plans to double its manufacturing capacity by the end of the year to meet potential demand. The drug will be sold at a list price of $1,059.87 per month, around 20% lower than the price of Wegovy, and Lilly is introducing a savings card program for those with commercial insurance. 

Lilly’s tirzepatide has already become a top-selling product for the company in treating diabetes, generating around $3 billion in revenue in the first three quarters of the year. The company’s market capitalization has soared to nearly $600 billion, making it the most valuable pharmaceutical company globally. In the United Kingdom, where Mounjaro is also approved for diabetes, the drug’s authorization has been expanded to include obesity.

Although the launch may not be as rapid as in the U.S. due to negotiated reimbursement deals, Lilly expects it to be available sooner than later. Doctors had previously prescribed the diabetes version, Mounjaro, off-label to patients with obesity. However, insurers have recently clamped down on off-label usage. The approval of Zepbound for obesity provides another treatment option for those with obesity medication coverage. 

The race to dominate the potentially $100 billion obesity market intensifies as both companies face challenges in meeting the high demand for effective obesity treatments. Novo Nordisk’s Wegovy has longer-term data supporting its safety and benefits, including reducing the risk of major cardiovascular problems in people with obesity.

Lilly’s ongoing trial for Zepbound is expected to conclude in 2027. While Lilly’s Zepbound boasts potential higher efficacy and a lower price, Novo Nordisk may have an edge in convincing insurers to cover Wegovy due to its longer-term data on cardiovascular benefits. 

Despite the supply challenges, both Lilly and Novo Nordisk are exploring next-generation therapies to meet the growing demand for effective obesity treatments. The availability of multiple approved drugs for obesity allows doctors to tailor treatments better for patients, and ongoing research aims to identify which patients respond best to specific obesity medications. 

As the pharmaceutical industry evolves in the obesity treatment space, the approval of Zepbound adds a valuable option for individuals struggling with obesity and provides hope for more effective and personalized treatments in the future. 

Reference  

StateNews, “Eli Lilly gets FDA approval to sell Mounjaro as obesity drug called Zepbound”  https://www.statnews.com/2023/11/08/obesity-eli-lilly-mounjaro-zepbound-fda/.