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.
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.
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.
