EU Regulator Determines Mounjaro Effective for Sleep Apnea, No Separate Approval Required

Regulatory Decision:
The European Medicines Agency (EMA) has determined that Eli Lilly's weight-loss drug Mounjaro (tirzepatide) does not need a separate indication for the treatment of obstructive sleep apnea (OSA)134.

Clinical Trial Results:
A phase 3 clinical trial showed that tirzepatide, the active ingredient in Mounjaro and Zepbound, significantly reduced symptom severity of OSA by nearly two-thirds in adults with obesity and OSA25.

Obesity and OSA Link:
Approximately 70% of individuals diagnosed with OSA also have obesity, highlighting the importance of addressing obesity in managing OSA25.

Product Information Update:
The EMA has allowed the inclusion of data on sleep apnea in Mounjaro's product information, enabling doctors to be aware of its effects on OSA4.

Potential Impact:
The use of tirzepatide for OSA could offer an alternative to traditional treatments like CPAP machines, which are often cumbersome and underutilized5.

Sources:

1. https://seekingalpha.com/news/4386252-lillys-mounjaro-does-not-need-separate-approval-for-sleep-apnea-ema-panel-determines

2. https://www.medicalnewstoday.com/articles/zepbound-mounjaro-improves-sleep-apnea-symptoms

3. https://endpts.com/emas-committee-says-expanded-label-for-lillys-mounjaro-into-sleep-apnea-not-necessary/

4. https://www.bloomberg.com/news/articles/2024-12-13/eli-lilly-s-mounjaro-won-t-have-separate-sleep-apnea-label-in-eu

5. https://www.siumed.org/blog/can-weight-loss-drugs-help-sleep-apnea