SILVER SPRING, Md., Dec. 20, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity.

"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."

OSA occurs when a person's upper airway becomes blocked, causing pauses in breathing during sleep. While OSA can affect anyone, it is more common in people who have overweight or obesity. Zepbound works by activating receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) to reduce appetite and food intake. By reducing body weight, studies show that Zepbound also improves OSA.

Zepbound's approval for moderate to severe OSA in adults with obesity is based on two randomized, double-blind, placebo-controlled studies of 469 adults without type 2 diabetes. One study enrolled participants using positive airway pressure (PAP), the standard of care for moderate to severe OSA, and one study enrolled participants unable or unwilling to use PAP. In both studies, participants randomly received either 10 or 15 milligrams of Zepbound or placebo once weekly for 52 weeks. The primary measure of efficacy was the change from baseline in the apnea hypopnea index (AHI), a measurement of how many times a person stops breathing (apnea) or breathes shallowly (hypopnea) per hour during sleep, at week 52. After 52 weeks of treatment in both studies, participants who received Zepbound experienced a statistically significant and clinically meaningful reduction in events of apnea or hypopnea as measured by AHI compared with placebo, and greater proportions of participants treated with Zepbound achieved remission or mild OSA with resolution of symptoms compared to placebo. Participants treated with Zepbound had a significant decrease in body weight compared with placebo at 52 weeks. The improvement in AHI in participants with OSA is likely related to body weight reduction with Zepbound.

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

Zepbound causes thyroid C-cell tumors in rats. It is unknown whether Zepbound causes such tumors, including medullary thyroid cancer, in humans. Zepbound should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2.

Zepbound should not be used in patients with a history of severe allergic reaction to tirzepatide (its active ingredient) or to any of its other ingredients. Patients should stop Zepbound immediately and seek medical help if a severe allergic reaction is suspected.

Zepbound also contains warnings for inflammation of the pancreas (pancreatitis), gallbladder problems, hypoglycemia (blood sugar that is too low), acute kidney injury, diabetic retinopathy (damage to the eye's retina) in patients with type 2 diabetes mellitus, suicidal behavior or thinking, and pulmonary aspiration during general anesthesia or deep sedation. Patients should discuss with their health care provider if they have symptoms of pancreatitis or gallstones. If Zepbound is used with insulin or a medication that causes insulin secretion, patients should speak to their health care provider about potentially lowering the dose of these other medicines to reduce the risk of hypoglycemia. Health care providers should monitor patients with kidney disease, diabetic retinopathy and depression or suicidal behaviors or thoughts. Patients taking Zepbound should inform healthcare providers of any planned surgeries of procedures.

Zepbound received Fast Track , Priority Review and Breakthrough Therapy designations for this indication.

The FDA granted the approval to Eli Lilly and Co.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration