The US Food and Drug Administration has approved a new medication – the first, in fact — for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
The medication, — Zepbound (tirzepatide), is to be used in combination with a reduced-calorie diet and increased physical activity.
Zepbound received Fast Track, Priority Review and Breakthrough Therapy designations for this indication. The FDA granted the approval to Eli Lilly and Co. The medication, administered by injection, became available in Israel this past September under the brand name “Mounjaro.”
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, MD, 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. Untreated OSA can be very dangerous and eventually fatal, due to the medical conditions caused by the interruption of oxygen to the brain.
While OSA can affect anyone, it is more common in people who are overweight or obese.
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 showed that Zepbound also improves OSA. The FDA approval was 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, or CPAP), (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 compared with placebo. In addition, a greater proportion 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. According to the FDA, the improvement in participants with OSA is likely related to body weight reduction with Zepbound.
Side effects of the medication include 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 (GERD).
Because Zepbound caused thyroid C-cell tumors in rats, the medication 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, the FDA said. Zepbound should also not be used in patients with a history of severe allergic reaction to tirzepatide (its active ingredient) or to any of its other ingredients. Other warnings include those for the possible development of pancreatitis, gall stones and other conditions.
