Topline
Eli Lilly’s weight loss injection tirzepatide — the ingredient inside its wildly popular drugs Mounjaro and Zepbound — could also help treat sleep apnea, according to research published Friday, a potential gamechanger for the common condition that bolsters the case for GLP-1 insurance coverage amid mounting evidence the drugs have numerous medical benefits beyond managing diabetes and weight loss.
Key Facts
Sleep apnea is a common condition where breathing repeatedly starts and stops during sleep, which slashes the amount of oxygen available to the body and boosts the risk of serious health conditions including high blood pressure, stroke, heart attack, diabetes and dementia.
It is commonly caused when the upper airway becomes blocked, known as obstructive sleep apnea, but also happens if the brain doesn’t send the correct signals needed for breathing.
Tirzepatide significantly reduced the number of breathing interruptions during sleep — a key measure of disease severity — for clinically obese people living with moderate-to-severe obstructive sleep apnea, according to the results of two clinical trials published in the New England Journal of Medicine.
The study, which involved a global team of researchers and was partly funded by Eli Lilly, evaluated different doses of tirzepatide or placebo over the course of a year in 469 patients recruited from nine countries, including the U.S., Australia and Germany, some of whom used continuous positive airway pressure (CPAP) machines when sleeping to keep their airways open.
Some patients improved to such an extent that they may no longer require CPAP therapy, the researchers found, a potential boon for the many patients who don’t use the machines and a development the study’s lead author, Atul Malhotra, said could potentially transform how clinicians approach and treat the condition.
Could Zepbound And Mounjaro Become The First Drug Therapies For Sleep Apnea?
Lilly announced preliminary results from the trial in April and said tirzepatide reduced sleep apnea severity by nearly two-thirds. Lilly said it would start submitting data to the Food and Drug Administration and other global drug regulators beginning mid-year with a view to expanding tirzepatide’s label to include treating sleep apnea. The company has already received a fast track designation for moderate-to-severe OSA and obesity from the FDA and, if authorized, would become the first pharmaceutical treatment for the underlying causes of sleep apnea.
Big Number
1 billion. That’s how many people are estimated to be living with obstructive sleep apnea worldwide. Lilly said the condition impacts some 80 million people in the U.S., 20 million of whom are living with moderate-to-severe OSA.
What We Don’t Know
The size of the sleep apnea market for tirzepatide is significant but hidden as the majority of OSA cases “go undiagnosed and therefore untreated,” said Lilly’s senior vice president of product development Jeff Emmick. “Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease,” Emmick said.
Key Background
These results add to a growing pile of research that indicates the health benefits of popular weight loss and diabetes injections extend far beyond those conditions, including potential for treating heart disease, kidney disease, addiction and Parkinson’s. Much of this research suggests the medical benefits are not just the result of managing blood sugar and shedding weight, though this does improve health, but result from other mechanisms of action as well. The ability to market GLP-1 drugs like semaglutide (sold as Ozempic and Wegovy for diabetes and weight loss) and tirzepatide for additional indications has become a key strategy for drugmakers Novo Nordisk and Lilly to stay ahead of competitors racing to bring their own weight loss drugs to market. Novo has already secured one victory by demonstrating the heart benefits of semaglutide, expanding Wegovy’s label to reflect this. Ultimately, such data will also make it increasingly difficult for insurers to continue denying patients coverage for the costly drugs. The ongoing reluctance of health plans and employers to cover the expensive medicines is a significant and growing issue for the companies as the popularity of the treatments has skyrocketed.
Get Forbes Breaking News Text Alerts: We’re launching text message alerts so you’ll always know the biggest stories shaping the day’s headlines. Text “Alerts” to (201) 335-0739 or sign up here.
Read the full article here