The mega-blockbuster weight loss GLP-1 drug is now also approved to treat obstructive sleep apnea in adults with obesity, in combination with diet and exercise.
Eli Lilly’s weight loss blockbuster has snagged the first ever FDA drug approval for obstructive sleep apnea. The expanded indication announcement sent the company’s stock up 7.5% to over $813 a share Friday morning.
Tirzepatide, first approved for type 2 diabetes, exploded in 2023 when the FDA approved it for weight loss as Zepbound. The drug is a dual agonist of the GLP-1 and GIP receptors—key mediators of insulin secretion that also suppress appetite.
The new approval is for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity, to be used in combination with diet and exercise. The SURMOUNT-OSA Phase III trial showed that Zepbound was five times more effective in reducing breathing disruptions in adults not on positive airway pressure (PAP) therapy—the go-to medical device for those with sleep apnea. After 52-weeks, 50% of those on the drug plus a PAP machine achieved either remission or mild, non-symptomatic OSA compared to 14% on placebo. The drug alone was also efficacious with 42% experiencing remission or mild OSA at one year.
In the U.S., an estimated 30-90 million people have OSA but only 6 million are diagnosed. The condition is associated with increased risk of heart disease, stroke and workplace errors.
Sales for Lilly’s two forms of tirzepatide, Mounjaro and Zepbound, were a cumulative $4.37 billion for the third quarter of 2024. This fell a bit short of analyst expectations, primarily due to drug shortages which allowed compounding pharmacies to develop cheaper, unbranded versions of the drug. Last Thursday, the FDA announced that the shortage has resolved. Pharmacies that had previously been approved for compounding now have 60 to 90 days to stop making versions of the drug.
Lilly has invested heavily to ensure the drug doesn’t end up back on the list, with a $3 billion expansion of a recently acquired manufacturing facility in Wisconsin announced earlier this month.
GLP-1 drugs are exploding in popularity in the obesity space. Since Novo Nordisk’s semaglutide was approved in a cardiovascular indication in March, the drug type is now being explored across a myriad of indications including chronic kidney disease, metabolic dysfunction-associated steatohepatitis, Alzheimer’s, cancers and even addiction.
While Medicare has historically barred coverage of obesity medications, additional indication approvals have expanded access to the drugs for millions of Americans. The Biden administration has now proposed a new rule that would classify obesity drugs as treatments for “chronic disease,” rather than weight loss medications. The change would dramatically reduce out-of-pocket costs for the $1,000+ monthly drugs for the 3.4 million Americans on Medicare and another 4 million enrolled in Medicaid, according to White House officials.
