Zepbound’s clinical tests in obstructive sleep apnea showed improvement in breathing disruptions that were accompanied by reductions in body weight. The new approval gives the Eli Lilly medicine the opportunity to become a blockbuster seller in yet another indication.
Sleep apnea, a sleep disorder typically managed with a medical device that aids in breathing, now has its first FDA-approved drug therapy, an Eli Lilly medicine initially developed as a treatment for metabolic conditions.
The FDA late Friday approved Lilly’s tirzepatide, brand name Zepbound, for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. The product’s prescribing information instructs use of the once-weekly injectable medication in combination with a reduced-calorie diet and exercise, the same as the instructions for its applications in type 2 diabetes and weight management.
OSA is caused by blockage of the upper airway that leads to pauses in breathing while a person is sleeping. Standard treatment of this chronic condition is continuous positive airway pressure (CPAP), a medical device and mask worn while a patient is sleeping. The device provides constant airflow to maintain an open airway.