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Eli Lilly and Company LLY announced that the FDA has approved its popular obesity drug, Zepbound (tirzepatide) for treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. OSA is a common sleep-related breathing disorder that causes repeated interruptions in breathing (apnea) or shallow breathing (hypopnea) during sleep. OSA marks the second indication for Zepbound. The drug was approved to treat obesity or overweight issues in November 2023.
With the approval, Zepbound becomes the first and only prescription drug approved for treating for adults with moderate-to-severe OSA and obesity.
LLY’s stock was up 1.4% on Friday. It is also up in-premarket trading on Monday in response to the new approval. Also, rival Novo Nordisk NVO announced disappointing data from a late-stage study on its next-generation obesity drug, CagriSema, on Friday, which also pushed LLY’s stock up.
Lilly’s stock has risen 31.7% so far this year compared with an increase of 1.4% for the industry.
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More on the FDA Approval for LLY’s Zepbound for OSA
Zepbound’s approval for OSA was based on data from SURMOUNT-OSA phase III studies, which showed that patients not on positive airway pressure (PAP) therapy taking Zepbound experienced 25 fewer breathing disruptions per hour compared to five with placebo. In adults taking PAP therapy, Zepbound led to 29 fewer breathing disruptions per hour compared to six with placebo. In addition to improved OSA symptoms, in adults with PAP therapy, Zepbound also led to an average weight loss of 20%. The studies also showed that around 50% of the patients experienced such improvements with Zepbound that they no longer had symptoms associated with OSA after one year.
Lilly’s regulatory application seeking approval of Zepbound for OSA is also under review in the EU.
New Indications to Expand LLY’s Tirzepatide Label
Other than Zepbound, Lilly markets tirzepatide as Mounjaro for type II diabetes. Mounjaro and Zepbound have seen great success generating huge revenues for Lilly.
Lilly has also filed regulatory applications in the United States and EU to seek approval for tirzepatide for heart failure with preserved ejection fraction (HFpEF). A phase III cardiovascular outcome study is also ongoing.A phase II study in metabolic dysfunction-associated steatohepatitis (MASH) met its primary endpoint in 2024. Approval for these expanded indications can further boost tirzepatide’s sales.
Despite a short time on the market, Mounjaro and Zepbound have become key top-line drivers for Lilly in 2024, with demand rising rapidly.