MONDAY, Dec. 23, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Zepbound (tirzepatide) as the first prescription medication for the treatment of obstructive sleep apnea (OSA).
In a news release published Dec. 20, the FDA stated that Zepbound, a glucagon-like peptide-1 receptor agonist, was cleared to treat moderate-to-severe OSA in patients with obesity. According to drugmaker Eli Lilly, the treatment is intended for use alongside a reduced-calorie diet and increased physical activity.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care in the FDA Center for Drug Evaluation and Research, said in a news release. “This is a major step forward for patients with obstructive sleep apnea.”
“Many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” Patrik Jonsson, president of Lilly Cardiometabolic Health, said in a news release from the company. In clinical trials, he noted, nearly half of Zepbound users saw such significant improvements that their OSA symptoms resolved.
FDA approval for Zepbound in treating sleep apnea was based on two previous Eli Lilly-sponsored trials published in the New England Journal of Medicine involving nearly 470 participants, some of whom were using continuous positive airway pressure (CPAP) machines.
In one trial in which participants did not use CPAP, Zepbound reduced apnea-hypopnea index events by an average of 25 per hour after one year compared with a reduction of just five events in the placebo group. In the trial involving CPAP users, Zepbound reduced events by 29 per hour on average versus six in the placebo group.
The FDA approval is only for people with obesity, but it could help those with sleep apnea get Medicare coverage, which currently does not cover drugs just for weight loss.
Eli Lilly has emphasized its commitment to accessibility, offering patient support programs, including a lower-cost vial option, to help ease financial barriers. However, without insurance, monthly costs can still exceed $1,000.
Approval of this indication for Zepbound was granted to Eli Lilly.
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