Eli Lilly announced today that its blockbuster weight-loss drug Zepbound was approved by the U.S. Food and Drug Administration (FDA) as the first prescription drug to help alleviate moderate-to-severe obstructive sleep apnea (OSA) for adults with obesity.
This approval could expand access to the medication, allowing Zepbound to join Novo Nordisk’s competing weight-loss drug Wegovy in being covered by Medicare.
“Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges,” said Patrik Jonsson, president of Lilly Cardiometabolic Health and Lilly USA, in a press release.
The approval is based on a clinical trial from earlier this year, which showed Zepbound was five times more effective than a placebo in reducing breathing disruptions, with 25 fewer disruptions per hour compared to five with placebo.
The drug was tested on 469 participants with obesity and moderate-to-severe OSA, a breathing disorder where a person’s upper airway collapses completely or partially during sleep.
In a group that was not on a positive airway pressure (PAP) therapy — like what’s known as a CPAP machine — the medication reduced the average number of times a participants’s breathing showed a restricted or complete block of airflow by 27.4 events per hour (55%) from baseline after 52 weeks.
In another group, which continued on a PAP therapy for the 52 weeks, the average number of restricted or blocked breathing events was reduced by an average of 30.4 events per hour (62.8%). In addition, the two groups lost an average of body weight from baseline of 18% and 20%, respectively.
The news also opens the door for Zepbound to be covered by federal health insurance in the United States. In March, the U.S.Centers for Medicare and Medicaid Services (CMS) issued new guidance stating that “that anti-obesity medications that receive FDA approval for an additional medically accepted indication can be considered a Part D drug for that specific use.”
The guidance was issued about a week after U.S. regulators expanded the approved use of Wegovy to include reducing heart risks for adults who are obese or overweight.
