FDA approves Zepbound for obstructive sleep apnea

On Dec. 20, 2024, the FDA approved tirzepatide, a dual glucagon-like peptide-1 and glucose-dependent insulinotropic peptide receptor agonist, as the first medication to treat obstructive sleep apnea.

"Today's approval marks the first drug treatment option for certain patients with obstructive sleep apnea," said Sally Seymour, M.D., director of the division of pulmonology, allergy and critical care in the FDA's Center for Drug Evaluation and Research. "This is a major step forward for patients with obstructive sleep apnea."

Tirzepatide, sold under the brand name Zepbound, is a once-weekly injectable GLP-1 medication previously approved for weight loss in patients with overweight or obesity. Another version of the drug, sold as Mounjaro, is approved for managing type 2 diabetes. In this approval, the FDA has expanded indications for Zepbound beyond weight loss, adding the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity to the approved indications.

Obstructive sleep apnea is defined as pauses in breathing while asleep due to an obstructed upper airway. According to the FDA, the condition can affect anyone but is more prevalent in individuals with overweight or obesity.

Combined with physical activity and dietary changes, Zepbound can reduce body weight by suppressing appetite. Studies have shown that obstructive sleep apnea can also improve in patients taking these drugs.

The FDA based this expanded indication on two randomized, double-blind, placebo-controlled clinical studies on patients with moderate-to-severe obstructive sleep apnea and obesity. While one study enrolled participants using positive airway pressure (PAP), a common treatment for obstructive sleep apnea, the other study enrolled participants who could not or were unwilling to use PAP.

Participants in both studies were randomized to one of two doses of Zepbound (10 mg or 15 mg) or a placebo, administered once weekly for 52 weeks.

To evaluate the medication's efficacy, researchers looked at the apnea-hypopnea index (AHI), which measures the number of times a person stops breathing or breathes shallowly per hour during sleep, before and after taking the medication for 52 weeks.

According to the FDA press release, in both studies, patients taking Zepbound had a significantly lower AHI than those taking the placebo. In addition, a greater portion of patients taking Zepbound achieved remission or mild obstructive sleep apnea and symptom resolution than those taking the placebo. Researchers linked these outcomes to greater body weight reduction among participants taking Zepbound.

Despite these benefits, the FDA lists and acknowledges the potential side effects and unknown risks associated with the drug. Providers and patients should exercise caution when it comes to these medications.

Although caution with GLP-1 medications has been advised across the board, this expanded approval hints at the potential expanded uses for this class of drugs.

Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.