Eli Lilly Anticipates Zepbound Label Expansion Following Positive Phase III Sleep Apnea Study Results

1. Eli Lilly announced on Wednesday, April 17, 2024, the successful completion of the Phase III SURMOUNT-OSA study, which demonstrated symptom improvements in obstructive sleep apnea (OSA) patients treated with Zepbound (tirzepatide).
2. Zepbound is Eli Lilly's top-selling weight-loss drug, and it has previously earned the FDA's Fast Track designation for moderate-to-severe OSA.
3. The SURMOUNT-OSA study was a randomized, double-blinded, and placebo-controlled study involving 469 participants with OSA and obesity.
4. Patients treated with Zepbound showed a mean reduction of 27.4 events per hour in the apnea-hypopnea index (AHI) in the first part of the study, while placebo counterparts saw a reduction of 4.8 events per hour.
5. In the second part of the study, Zepbound-treated patients reached a mean AHI reduction of 30.4 events per hour, compared to 6.0 events per hour for placebo comparators.
6. The safety profile of Zepbound in SURMOUNT-OSA was consistent with previous trials, with the most common side effects being gastrointestinal in nature and mild to moderate in severity.
7. Eli Lilly plans to submit the data to the FDA and other global health regulatory agencies by mid-year, aiming for a label expansion to include the treatment of obstructive sleep apnea.
8. If approved, Zepbound could address the unmet medical need for pharmaceutical treatments of the underlying OSA disease, as there are currently only pharmaceutical treatments for the excessive sleepiness associated with OSA.
9. The readout adds to the growing list of diseases where GLP-1 receptor agonists, like tirzepatide, appear to be effective.
10. Eli Lilly's announcement comes shortly after Novo Nordisk's approval of Wegovy (semaglutide) to lower the risk of cardiovascular events and Boehringer Ingelheim's positive results for survodutide in metabolic dysfunction-associated steatohepatitis.