Eli Lilly has achieved a significant milestone by securing U.S. Food and Drug Administration (FDA) approval for Zepbound (tirzepatide) as a treatment for obstructive sleep apnea (OSA) in adults with obesity. This landmark approval positions Lilly ahead of Novo Nordisk in the race to provide pharmaceutical solutions for OSA, a condition affecting millions globally.
Zepbound is now the first medication to receive FDA approval specifically for moderate to severe OSA in individuals who are obese. The drug is intended to be used alongside a reduced-calorie diet and increased physical activity, addressing a key underlying factor of the condition—excess weight.
OSA is characterized by repeated interruptions in breathing during sleep due to airway blockages. While anyone can develop OSA, it is more prevalent in individuals with excess body weight. Zepbound functions by stimulating receptors for gut hormones – glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). This dual action curbs appetite and reduces food consumption, contributing to weight loss. Research indicates that this weight reduction correlates with improvements in OSA symptoms.
The FDA’s decision to approve Zepbound for OSA was informed by two clinical trials involving 469 adults without type 2 diabetes. These randomized, double-blind, placebo-controlled studies assessed the drug’s effectiveness over 52 weeks. One trial included participants who were using positive airway pressure (PAP) therapy – the standard treatment for moderate to severe OSA – while the other focused on those who either could not tolerate or declined PAP. Participants were randomly assigned to receive weekly doses of either 10 or 15 milligrams of Zepbound or a placebo.
The main goal of the trials was to measure changes in the apnea-hypopnea index (AHI), which tracks the frequency of breathing disruptions per hour during sleep. After one year, participants who received Zepbound demonstrated significant reductions in their AHI scores compared to those on placebo. A greater number of participants treated with Zepbound achieved either remission or mild OSA with noticeable symptom improvement. Additionally, those taking Zepbound experienced more substantial weight loss than participants receiving placebo, suggesting that reductions in body weight were a contributing factor to OSA improvements.
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