FDA approves Zepbound for moderate to severe OSA, obesity

Key takeaways:

• Zepbound demonstrated significantly more efficency than placebo in treating adults with OSA.
• The drug was also associated with significant weight loss at one year.

The FDA has approved Zepbound (tirzepatide), a prescription medicine for adults with moderate to severe obstructive sleep apnea and obesity, Eli Lilly and Company announced in a press release.

“Too often, OSA is brushed off as ‘just snoring’ — but it’s far more than that,” Julie Flygare, JD, president and CEO of Project Sleep, said in the release. “It’s important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes.”

The drug was approved after results from the SURMOUNT-OSA phase 3 clinical trials, which evaluated Zepbound 10 mg or 15 mg. The trials found the drug was five times more effective than placebo in adults not using positive airway pressure (PAP) therapy and led to 25 fewer breathing disruptions per hour compared to placebo in those that were using PAP. After one year of treatment, 42% of the participants using Zepbound alone and 50% of those using the drug alongside PAP experienced either remission or mild, non-symptomatic OSA, compared with 16% of the placebo group not using PAP and 14% of those using PAP.

Participants using Zepbound also experienced weight loss, losing an average of 45 lbs in the study period. Those using combination therapy lost an average of 50 lbs, while the placebo PAP users lost 6 lbs and the placebo non-PAP users lost 4 lbs.

“Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity,” Patrick Jonsson, executive vice president and president of Lilly Cardiometabolic health and president of Lilly USA, said in the release. “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.”