Eli Lilly to seek label expansion for Mounjaro, Zepbound

After achieving promising outcomes for patients with sleep apnea, Eli Lilly said April 17 it plans to seek a wider FDA approval for Mounjaro and Zepbound. 

Among adult study participants with moderate to severe obstructive sleep apnea and obesity, about 30 fewer sleep apnea events per hour happened while taking tirzepatide — the active pharmaceutical ingredient for Type 2 diabetes drug Mounjaro and weight loss medication Zepbound. 

The drugmaker used the apnea-hypopnea index, which records the number of times per sleeping hour a person's breathing is restricted or blocked. 

Eli Lilly conducted two phase 3 trials testing the medicine among adults who do and do not use positive airway pressure therapy. Among patients not using PAP therapy, tirzepatide reduced an average of 27.4 events per hour, and for those using PAP, 30.4 events per hour were avoided. 

After 52 weeks, the patients taking tirzepatide lost nearly 20% of their body weight, Eli Lilly said in a news release. The drugmaker said it would apply for expanded drug labels by mid-2024. 

Wegovy, Novo Nordisk's weight loss drug, has the potential to cut 10.7% of obstructive sleep apnea cases by 2030, according to one forecast. Read more about sleep apnea and weight loss medications here.

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