Lil­ly plans for Zep­bound la­bel ex­pan­sion in­to sleep ap­nea in mid-2024 on back of Phase 3 win

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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