(Bloomberg) -- Eli Lilly & Co.’s weight-loss shot Zepbound won approval in the US as the first drug to treat sleep apnea, opening the door for broader insurance coverage of the blockbuster medicine.
The drug was cleared for people with moderate to severe obstructive sleep apnea and obesity, and should be used in conjunction with diet and exercise, the company said in a statement. The drug’s benefit likely stems from the patients’ weight loss, the Food and Drug Administration said.
Sleep apnea is a breathing disorder often tied to obesity that affects more than 23 million American adults. Treatment typically involves opening the airways with the use of breathing machines and masks, or implants. While there are medicines that ease drowsiness associated with the condition, Zepbound is the first drug to address the underlying disease.
“This is a major step forward for patients with obstructive sleep apnea,” Sally Seymour, director of the FDA’s division of pulmonology, allergy, and critical care, said in a statement. “Today’s approval marks the first drug treatment option” for the condition, she said.
The approval could make it easier for some people to get Zepbound. Medicare, the government’s insurance program for the elderly, doesn’t pay for weight loss drugs, though the Biden administration has proposed changing that. It also gives Lilly more ammunition in its competition with Novo Nordisk A/S, whose obesity drug, Wegovy, is covered by Medicare prescription drug plans for some patients with heart-related conditions.
Novo has said it may study a next-generation weight-loss drug for sleep apnea, but it’s not testing whether Wegovy or its diabetes medicine Ozempic help with the condition.
Zepbound’s new approval is based on two late-stage trials of patients with obesity and obstructive sleep apnea that compared use of the drug to placebo over the course of a year. The effects were dramatic.
In one study, the medicine led to 25 fewer breathing disruptions per hour, compared to five fewer for people who given a placebo. In the second study, involving patients also using breathing devices, there were 29 fewer breathing disruptions per hour among those given Zepbound, compared with six fewer among those on placebo.
Many people taking Zepbound went into remission, with nearly half exhibiting only mild or no symptoms of the condition. They also lost an average of 18% to 20% of their body weight.
The studies enrolled 469 patients, and measured hourly episodes of reduced airflow or pauses in breathing during sleep. The condition is often marked by snoring and can also cause disrupted sleep and fatigue.
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