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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowThe U.S. Food and Drug Administration has approved Eli Lilly and Co.’s obesity-treatment Zepbound as the first medicine for adults with moderate-to-severe obstructive sleep apnea and obesity.
Lilly announced the news Friday, saying Zepbound might help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder.
Lilly’s stock was up slightly in after-hours trading.
Obstructive sleep apnea (or OSA) is a sleep-related breathing disorder characterized by complete or partial collapses of the upper airway during sleep, which can lead to pauses in breathing or shallow breathing and a potential decrease in oxygen saturation and/or waking from sleep. One of the hallmarks of OSA is snoring, but fatigue, excessive daytime sleepiness and disrupted sleep are also key symptoms, making the condition easily overlooked.
“Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health and Lilly USA said in a prepared statement. “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.”
The FDA’s approval was based on results from the SURMOUNT-OSA phase 3 clinical trials, which evaluated Zepbound for the treatment of moderate-to-severe OSA in adults with obesity, with and without positive airway pressure therapy over the course of a year.
Zepbound was about five times more effective than placebo in reducing breathing disruptions in adults not on PAP therapy, leading to 25 fewer breathing disruptions per hour with Zepbound and five with placebo. In adults on PAP therapy, Zepbound led to 29 fewer breathing disruptions per hour compared with six with placebo. After one year, 42% of adults on Zepbound and 50% of adults on Zepbound with PAP therapy experienced remission or mild, non-symptomatic OSA, compared with 16% and 14% on placebo, respectively.
In addition to improved OSA symptoms, adults on Zepbound lost an average of 45 pounds, while adults on Zepbound with PAP therapy lost an average of 50 pounds, compared with 4 pounds and 6 pounds on placebo, respectively.
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Now we just need insurance companies to cover the meds.
Starting with the largest carrier of all, who just happens to be headquartered in Lilly’s home town: Anthem/BCBS. Medicaid is covering it in many states but not Anthem.