New Sleep Apnea Indication for Lilly’s Zepbound

FDA has approved a new indication for Lilly’s Zepbound (tirzepatide) to treat moderate to severe obstructive sleep apnea in adults with obesity when used in combination with a reduced-calorie diet and increased physical activity. An agency statement says the approval for this indication was based on results from two clinical studies, one with patients using positive airway pressure (PAP) and one with patients unable or unwilling to use PAP.

FDA says the primary measure of efficacy was the change from baseline in the apnea-hypopnea index. It says Zepbound can cause side effects such as nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, hypersensitivity reactions, burping, hair loss, and gastroesophageal reflux disease.

Zepbound received fast track, priority review, and breakthrough therapy designations for this indication.