Eli Lilly's tirzepatide, a dual GIP and GLP-1 receptor agonist already marketed as Mounjaro for type II diabetes and Zepbound for obesity, has demonstrated promising results in treating obstructive sleep apnea (OSA). Recent data from the SURMOUNT-OSA phase III study revealed that tirzepatide significantly reduced sleep apnea events in obese adults.
SURMOUNT-OSA Trial Results
The SURMOUNT-OSA phase III study evaluated tirzepatide for moderate-to-severe OSA in adults with obesity, both with and without positive airway pressure (PAP) therapy. The results, announced by Lilly, showed that patients with OSA and obesity experienced approximately 30 fewer disruptive events every hour of sleep. Notably, 51.5% of patients using PAP machines achieved disease resolution.
Based on these findings, Lilly has submitted a regulatory application to the FDA seeking approval of tirzepatide for the treatment of moderate-to-severe OSA and obesity, with plans to file applications to other regulatory bodies soon.
Market Impact and Analyst Expectations
If approved for expanded use in OSA, sales of tirzepatide are projected to increase substantially. Analysts estimate that tirzepatide could generate around $25 billion in peak sales, further establishing its dominance in the GLP-1 segment. This class of drugs, which mimics the GLP-1 hormone, is gaining popularity for its effectiveness in weight loss, lowering hemoglobin A1c, and reducing cardiovascular risks.
Tirzepatide faces competition from Novo Nordisk's semaglutide, marketed as Ozempic and Rybelsus for type II diabetes and Wegovy for weight management. Despite supply challenges, Wegovy continues to generate significant revenue for Novo Nordisk.
Lilly's Broader Pipeline and Financial Performance
In addition to Mounjaro and Zepbound, Lilly has recently gained approvals for other new drugs, including Omvoh for ulcerative colitis and Jaypirca for mantle cell lymphoma and chronic lymphocytic leukemia. The company anticipates that these new drugs, along with Mounjaro, Omvoh, Zepbound, Ebglyss, and Jaypirca, will significantly contribute to its revenue in 2024.
A key asset in Lilly’s pipeline is donanemab for early Alzheimer’s disease, currently under FDA review. An FDA committee recently voted unanimously in favor of its approval, citing that the benefits outweigh the risks. If approved, donanemab would be the second drug on the market for treating Alzheimer's disease, following Biogen and Eisai’s Leqembi.
Lilly's stock has risen significantly in recent years, driven by its strong pipeline potential, particularly in obesity and diabetes. Analysts have increased their earnings estimates for Lilly, reflecting optimism about the company's future growth.
