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FDA Approves Zepbound to Treat Obstructive Sleep Apnea

The U.S. Food and Drug Administration (FDA) has authorized the use of  Eli Lilly & Co.’s Zepbound for adults with obesity and moderate to severe obstructive sleep apnea (OSA), a common condition where a person struggles to breathe properly during sleep. It is the first prescription medication approved to treat obstructive sleep apnea.

Approval is based on studies that have shown that by aiding weight loss, Zepbound helps reduce sleep apnea symptoms in some patients. In two studies with adults who had obesity and moderate to severe OSA over a 52-week period, participants who received Zepbound experienced a “statistically significant and clinically meaningful reduction” in episodes of shallow breathing or temporary pauses in breathing while asleep compared to those who received a placebo, according to FDA. That was true for both participants who used a CPAP machine and those who do not.

“This is a major step forward for 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.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.