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FDA Approves Tirzepatide as First Treatment for Moderate-to-Severe Obstructive Sleep Apnea in Adults With Obesity
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Key Takeaways
- Tirzepatide is FDA-approved for moderate-to-severe OSA in adults with obesity, combined with diet and exercise.
- SURMOUNT-OSA trials showed tirzepatide significantly reduced apnea-hypopnea index and breathing disruptions compared to placebo.
The new approval continues to expand the therapeutic potential of GLP-1 medications such as tirzepatide, now being deemed effective in patients with obstructive sleep apnea.
FDA officials granted regulatory approval to tirzepatide (Zepbound; Eli Lilly and Company) as the first and only prescription medicine for adult patients with moderate-to-severe obstructive sleep apnea (OSA) and obesity, in combination with a reduced-calorie diet and increased physical activity, according to a news release from Lilly.1
Sleep apnea can be a complication of obesity or overweight. | Image Credit: © Andrii Lysenko | stock.adobe.com
The regulatory approval is based on study results from the SURMOUNT-OSA phase 3 clinical trials, which evaluated tirzepatide for the treatment of moderate-to-severe OSA in adults with obesity—with and without positive airway pressure (PAP) therapy—over the course of a year.1
“Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” Patrick Jonsson, executive vice president and president of Lilly USA, said in the news release.1
Previously garnered clinical trial results from SURMOUNT-OSA found that treatment with tirzepatide, both with and without a continuous PAP machine, led to improvements in apnea-hypopnea index from baseline to 52 weeks in patients with OSA and obesity. Portions of data from the series of trials was presented at the American Diabetes Association 84th Scientific Sessions.2
The news release also expands on other positive indicators stemming from the SURMOUNT-OSA trials of tirzepatide. Investigators found tirzepatide was almost 5 times more effective than placebo in reducing breathing disruptions in adults not on PAP therapy. This led to 25 fewer breathing disruptions per hour with tirzepatide, compared with 5 with placebo. Furthermore, regarding adults on PAP therapy, tirzepatide led to 29 fewer breathing disruptions per hour, compared to 6 with placebo.1
In addition, after 1 year of treatment, 42% of adults on tirzepatide and 50% of adults on tirzepatide with PAP therapy experienced remission or mild symptomatic OSA, compared with 16% and 14% on placebo, respectively, according to the news release.1
"[Tirzepatide] is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity,” Jonsson continued. “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."1
Affecting over 900 million patients across the world, the common respiratory disorder originates from insistent pharyngeal collapse during sleep, which results in a temporary pause of breathing or shallow breathing during sleep.3
The news release notes that tirzepatide should not be used with any other tirzepatide-containing products, nor any GLP-1 receptor agonist medicines. In addition, it is currently unknown whether the medication is safe and effective for use in children.1
"It's important to understand OSA symptoms and know that treatments are available, including new options like [tirzepatide],” Julie Flygare, JD, president and CEO of Project Sleep, said in the news release. “We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes."1
REFERENCES
1. Lilly. FDA approves Zepbound (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity. News Release. Released December 20, 2024. Accessed December 20, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-zepboundr-tirzepatide-first-and-only-prescription#:
2. Gallagher A. SURMOUNT-OSA: 4 in 10 who need CPAP would no longer need it with tirzepatide. Pharmacy Times. Published June 22, 2024. Accessed December 20, 2024. https://www.pharmacytimes.com/view/surmount-osa-4-in-10-who-need-cpap-would-no-longer-need-it-with-tirzepatide
3. Vinciguerra J. Tirzepatide could offer a novel approach to sleep apnea treatment Pharmacy Times. Published October 9, 2024. Accessed December 20, 2024. https://www.pharmacytimes.com/view/tirzepatide-could-offer-a-novel-approach-to-sleep-apnea-treatment
