OSA is usually treated with a mask worn during sleep, called a continuous positive airway pressure (CPAP) machine. Credit: Kateryna Mostova via Shutterstock.

Eli Lilly’s blockbuster obesity drug, Zepbound (tirzepatide), has secured a label expansion from the US Food and Drug Administration (FDA) for adults with obesity and moderate to severe obstructive sleep apnoea (OSA). 

A common sleep disorder characterised by repeated interruptions in breathing during sleep due to airway relaxation and narrowing, OSA is associated with obesity and aging and can lead to significant health complications, including cardiovascular issues and impaired quality of life. The condition is usually treated with a mask worn during sleep, called a continuous positive airway pressure (CPAP) machine. However, Zepbound has become the first prescription medication approved to treat OSA. 

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The FDA’s decision was informed by data from the SURMOUNT-OSA Phase III trials (NCT05412004). These studies evaluated Zepbound’s effectiveness in reducing breathing disruptions over the course of one year in adults with obesity, both with and without positive airway pressure (PAP) therapy. After one year, 42% of Zepbound users without PAP therapy and 50% with PAP therapy achieved remission or mild, non-symptomatic OSA, compared to 16% and 14% in placebo groups, respectively. 

In the announcement accompanying the approval, Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA said: “Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences.” 

Lilly has also said that Zepbound helped patients lose an average of 45 lbs, or 18% of their body weight, in the same studies. Patients who received both Zepbound and PAP therapy lost an average of 50 lbs, or 20% of their body weight, the company added. This is compared to 4 lbs and 6 lbs on placebo, respectively. 

The FDA approval comes amid growing discussion about the potential uses of weight loss drugs beyond treating obesity and diabetes. In addition to sleep apnoea, there has been increasing interest in exploring their potential to treat neurodegenerative disorders as well as respiratory disease and more.  

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Zepbound, a GLP-1 receptor agonist (RA), was initially approved in November 2023 for obesity management. It is also marketed under the brand name Mounjaro for type 2 diabetes. GLP-1 RAs, including tirzepatide and Novo Nordisk’s semaglutide (marketed as Wegovy and Ozempic), have seen rapid adoption due to their demonstrated efficacy in weight loss and glycaemic control. 

Eli Lilly reported combined sales of $5.4bn for Zepbound and Mounjaro in 2023, and projections from GlobalData suggest these figures could climb to $62.6bn by 2030, driven by demand and additional label expansions. 

GlobalData is the parent company of Pharmaceutical Technology.