FDA approves Zepbound for sleep apnea in obese adults

(NewsNation) — Zepbound became the first drug approved by the Food and Drug Administration to treat obstructive sleep apnea in obese adults earlier this month.

“This is a major step forward for patients with obstructive sleep apnea," Dr. Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a statement released Dec. 20.

Sleep apnea happens when someone's upper airway is blocked, causing their breathing to repeatedly stop and start throughout the night. The disorder can affect anyone but is more common in those who are overweight or obese, according to the FDA.

"Too often, OSA is brushed off as 'just snoring' — but it's far more than that," Julie Flygare, J.D., president and CEO of Project Sleep, said. "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."

Zepbound activates receptors of hormones secreted from the intestine and glucose-dependent insulinotropic polypeptide to reduce appetite and food intake.

Two studies of 469 adults where participants randomly received either 10 or 15 milligrams of Zepbound or a placebo every week for a year found that those who took the medication experienced a "statistically significant and clinically meaningful reduction in events of apnea or hypopnea," the FDA said. In addition, those who took Zepbound saw their body weight decrease significantly compared to those who were on a placebo.

The FDA says side effects for Zepbound include nausea, diarrhea, vomiting, constipation, stomach pain, reactions at the injection site, fatigue, allergic reactions, burping, hair loss and gastroesophageal reflux disease. As Zepbound causes thyroid C-cell tumors in rats, it should not be used for patients with a personal or family history of the disease, or in patients with Multiple Endocrine Neoplasia syndrome type 2, the FDA said.

Even though Zepbound can reduce sleep apnea's severity, the American Academy of Sleep Medicine notes that it is not a cure.

"For some patients who have sleep apnea, combining another treatment with Zepbound may be ideal," the association says. "Furthermore, weight loss from Zepbound must be maintained over time to continue experiencing a benefit for sleep apnea."

At least 25 million adults in the U.S. have sleep apnea, according to the National Healthy Sleep Awareness Project.

"Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences," Patrik Jonsson, executive vice president of Eli Lilly and president of Lilly Cardiometabolic Health and Lilly USA, said. "Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity. Nearly half of the 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."