The US Food and Drug Administration has approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnoea (OSA) in adults with obesity, along with a reduced-calorie diet and increased physical activity.

“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnoea,” said Sally Seymour, director of the division of pulmonology, allergy, and critical care at the FDA’s Center for Drug Evaluation and Research. 

OSA occurs when the 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 issues. Zepbound works by activating the receptors of hormones secreted from the intestine (glucagon-like peptide-1, or GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) to reduce appetite and food intake. Studies show that by reducing body weight, Zepbound also helps in the treatment of OSA.

Zepbound’s approval for moderate to severe OSA in adults with obesity is based on two randomised, 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 the other study enrolled participants unable or unwilling to use PAP. In both studies, participants randomly received either 10 or 15 mg of Zepbound or placebo once weekly for 52 weeks. Participants treated with Zepbound had a significant decrease in body weight, compared with placebo, at 52 weeks.

Zepbound can cause side effects including nausea, diarrhoea, abdominal pain, injection site reactions, hypersensitivity or allergic reactions (typically fever and rash), and so on. It causes thyroid C-cell tumours in rats. It is unknown whether Zepbound causes such tumours in humans. 

Zepbound also contains warnings for pancreatitis, hypoglycaemia (low blood sugar), suicidal behaviour, and so on. The approval was granted to Eli Lilly and Co.

(Source: FDA)