SILVER SPRING, Md., Dec. 20, 2024 — The U.S. Food and Drug Administration today approved Zepbound (tirzepatide) to treat moderate to severe obstructive sleep apnea (OSA) in obese adults. This treatment should be used alongside a reduced-calorie diet and increased physical activity.

“This approval marks the first drug option for treating obstructive sleep apnea in specific patients,” stated Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care within the FDA’s Center for Drug Evaluation and Research. “This represents significant progress for OSA patients.”

OSA happens when a person’s upper airway is blocked, leading to pauses in breathing during sleep. While it can affect anyone, it’s more prevalent in overweight or obese individuals. Zepbound works by activating receptors for gut hormones (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)), reducing appetite and food intake. Studies show that this weight reduction, achieved through Zepbound, also improves OSA.

Zepbound’s approval for moderate to severe OSA in obese adults is based on two randomized, double-blind, placebo-controlled trials involving 469 adults without type 2 diabetes. One trial included participants using positive airway pressure (PAP), the standard OSA treatment, while the other included participants unable or unwilling to use PAP. In both, participants randomly received either 10 or 15 milligrams of Zepbound or a placebo weekly for 52 weeks. The main efficacy measure was the change in apnea hypopnea index (AHI) from baseline at week 52. AHI measures breathing pauses (apnea) or shallow breaths (hypopnea) per hour of sleep. After 52 weeks, Zepbound recipients experienced a statistically significant and clinically meaningful AHI reduction compared to the placebo group, and a larger proportion achieved remission or mild OSA with symptom resolution. Zepbound users also had significantly lower body weight at 52 weeks. The AHI improvement is likely linked to Zepbound-induced weight loss.

Zepbound can cause side effects such as nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, hypersensitivity (allergic) reactions (usually fever and rash), burping, hair loss, and gastroesophageal reflux disease.

Zepbound causes thyroid C-cell tumors in rats. Its effect on human thyroid tumor development, including medullary thyroid cancer, is unknown. It shouldn’t be used by those with a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2.

Zepbound is contraindicated in patients with a history of severe allergic reactions to tirzepatide (its active ingredient) or other components. Patients should stop Zepbound and seek immediate medical attention if a severe allergic reaction is suspected.

Warnings also apply to pancreatitis, gallbladder problems, hypoglycemia (low blood sugar), acute kidney injury, diabetic retinopathy (eye damage) in type 2 diabetes patients, suicidal thoughts or behavior, and pulmonary aspiration during general anesthesia or deep sedation. Patients should discuss pancreatitis or gallstone symptoms with their doctor. When using Zepbound with insulin or insulin-secretagogues, dose adjustments may be necessary to reduce hypoglycemia risk. Healthcare providers should monitor patients with kidney disease, diabetic retinopathy, and depression or suicidal ideation. Patients should inform their healthcare provider about any planned surgeries or procedures.

Zepbound received , and designations for this indication.

Eli Lilly and Co. received FDA approval.

 

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SOURCE U.S. Food and Drug Administration