Eli Lilly’s weight loss drug Zepbound hit the primary endpoints in two Phase 3 trials for adults with obstructive sleep apnea and obesity, setting the stage for the first potential approval of a drug for the breathing disorder.
The company said Wednesday it now plans to begin submitting the data to the FDA and other countries in the middle of the year.
In the 52-week SURMOUNT-OSA Study 1, the GIP/GLP-1 injection led to a mean apnea-hypopnea index (AHI) reduction of 27.4 events per hour from baseline in patients who were not on a PAP machine to help them breathe. That’s in comparison to a mean AHI reduction from baseline of 4.8 events per hour for patients on placebo.
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