Eli Lilly's (LLY) Zepbound has received Food and Drug Administration (FDA) approval as a treatment for obstructive sleep apnea for adults with obesity, the drugmaker announced late Friday.

The approval comes after several trials earlier this year that showed the tirzepatide-based drug is five times more effective than a placebo at reducing breathing disruptions caused by obstructive sleep apnea (OSA) and in 50% of cases, completely preventing them.

Zepbound Was Five Times Better at Reducing Breathing Disruptions

Lilly said its final trial evaluated sleep apnea and weight loss in those taking Zepbound, with some patients using a traditional "positive airway pressure" (PAP) mask while sleeping and others using no mask. Among those not using a sleep apnea mask, Zepbound was about five times more effective than a placebo at reducing the number of breathing disruptions per hour, the company said.

"Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity," said Patrik Jonsson, president of Lilly USA.

The trials found that adults on Zepbound alone lost an average of 45 pounds, or 18% of their body weight, while those adults on Zepbound combined with PAP therapy lost an average of 50 pounds or 20% of their body weight.

"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," Jonsson said.

Zepbound got FDA approval to treat obesity and weight loss in November 2023, joining Eli Lilly's other tirzepatide-based drug, Mounjaro. The two drugs, along with Novo Nordisk's (NVO) Ozempic and Wegovy, have captured the majority of a surging weight-loss market that has grown substantially in recent years.

Eli Lilly shares were up 1.6% at midday Monday, having gained about 34% on the year. Shares of ResMed (RMD), a medical device company that makes much of its revenue through the sale of sleep apnea masks, were 4% lower on Monday and have been negatively affected previously by the sleep apnea trials for Zepbound.