Eli Lilly and Company (Lilly) has secured approval from the US Food and Drug Administration (FDA) for Zepbound (tirzepatide) to treat moderate-to-severe obstructive sleep apnoea (OSA) in adults with obesity.
This marks the first prescription medication approved for the condition and is intended for use alongside a reduced-calorie diet and increased physical activity.
OSA, a sleep-related breathing disorder, involves the partial or complete collapse of the upper airway during sleep, leading to interruptions in breathing or shallow breathing. These episodes, known as apnoea or hypopnoea, can lower oxygen levels and disrupt sleep patterns.
OSA is commonly linked to symptoms such as fatigue and excessive daytime sleepiness, but it is frequently undiagnosed due to the overlap with other conditions.
Lilly USA executive vice president and Lilly cardiometabolic health president Patrik Jonsson said: “Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences.
“Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity. Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges.”
The FDA’s approval was based on data from the SURMOUNT-OSA phase 3 clinical trials, which evaluated the safety and efficacy of Zepbound in adults with moderate-to-severe OSA and obesity over a 52-week period.
The trials assessed the impact of the drug both with and without positive airway pressure (PAP) therapy. Results showed that Zepbound significantly reduced breathing disruptions compared to placebo.
In patients not using PAP therapy, Zepbound reduced disruptions by 25 events per hour, compared to five events with placebo. Among those on PAP therapy, Zepbound reduced disruptions by 29 events per hour, compared to six with placebo.
The study also reported that 42% of participants treated with Zepbound and no PAP therapy achieved remission or mild, non-symptomatic OSA after one year.
For those combining Zepbound with PAP therapy, 50% achieved similar outcomes. In contrast, only 16% and 14% of participants on placebo experienced comparable improvements in their condition.
The SURMOUNT-OSA trials (NCT05412004) were conducted across multiple sites in the US, Australia, Brazil, China, Czechia, Germany, Japan, Mexico, and Taiwan.
A total of 469 participants were randomised to receive either Zepbound or a placebo in a 1:1 ratio. Participants were administered Zepbound at a maximum tolerated dose (MTD) of either 10mg or 15mg.
The study’s primary objective was to evaluate changes in the Apnoea-Hypopnoea Index (AHI) from baseline after 52 weeks.
Participants began treatment with a starting dose of 2.5mg, which was gradually increased by 2.5mg every four weeks until they reached their MTD. Those who tolerated 15mg remained on that dose, while others continued at 10mg if the higher dose was not tolerated.
The trial also demonstrated significant weight loss among participants treated with Zepbound. Those not using PAP therapy lost an average of 45 pounds, representing an 18% reduction in body weight, while participants using PAP therapy lost an average of 50 pounds, or 20% of their body weight.
By comparison, those on placebo recorded average weight losses of four pounds and six pounds, respectively, or 2% of body weight in both groups.
This approval follows the November 2023 FDA clearance of Zepbound for obesity or overweight in adults with weight-related medical complications.
Zepbound, which activates the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, addresses obesity by targeting the mechanisms regulating appetite and calorie consumption.
