FDA approves Tirzepatide for obstructive sleep apnea in Adults with obesity

UAE—The U.S. Food and Drug Administration (FDA) has approved Tirzepatide, a medication developed by Eli Lilly, as the first and only prescription treatment for adults dealing with both moderate-to-severe obstructive sleep apnea (OSA) and obesity.

This approval offers a new option for managing the condition, which has long been underdiagnosed and inadequately treated.

Tirzepatide, when combined with a reduced-calorie diet and regular physical activity, has shown promise in improving sleep disorders in adults suffering from OSA and obesity.

The approval is based on findings from the SURMOUNT-OSA Phase 3 clinical trials, which assessed the drug’s effectiveness in doses of 10 mg or 15 mg over a year.

The trials included patients with and without positive airway pressure (PAP) therapy, a common treatment for OSA.

The results demonstrated that Tirzepatide significantly reduced breathing disruptions during sleep.

The drug reduced breathing interruptions by an average of 25 events per hour for patients not on PAP therapy, compared to only five events with a placebo.

Among those using PAP therapy, Tirzepatide reduced interruptions by 29 events per hour, while the placebo reduced them by just six.

After one year, Tirzepatide proved transformative for many patients, with around 42% of those on the drug alone and 50% of those combining it with PAP therapy experiencing remission or mild, non-symptomatic OSA.

This was in stark contrast to remission rates of 16% and 14% for placebo groups, respectively.

Additionally, patients on Tirzepatide experienced substantial weight loss, averaging 45 lbs (18% body weight) without PAP therapy and 50 lbs (20% body weight) with PAP therapy. By comparison, placebo groups lost only 4 to 6 lbs.

Julie Flygare, J.D., president and CEO of Project Sleep, emphasized the importance of recognizing OSA as more than just snoring.

 “It’s vital to understand the symptoms and know there are effective treatments, including new options like Tirzepatide,” she noted, adding that this approval could foster meaningful conversations between patients and healthcare providers.

OSA, a sleep disorder marked by partial or complete airway collapses, can cause interrupted breathing, reduced oxygen levels, and poor sleep quality.

 Common symptoms include snoring, fatigue, and excessive daytime sleepiness. Unfortunately, many cases remain undiagnosed, putting individuals at risk for severe health issues.

Patrik Jonsson, an executive at Eli Lilly, highlighted the urgency of addressing undiagnosed OSA cases, which leave millions at risk for severe health complications.

He described Tirzepatide as a groundbreaking solution, not only for improving OSA symptoms but also for aiding significant weight loss.

Jonsson called this advancement a critical step in reducing the burden of OSA and its related health challenges. 

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