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Today, Eli Lilly and Company announced in its Q2 2024 earnings report,Applications have been submitted to regulatory authorities in Europe and the United States seeking approval for the blockbuster therapy tirzepatide to improve snoring in obese patients with moderate to severe obstructive sleep apnea (OSA).The financial report pointed out that this indication is likely to receive FDA approval by the end of this year at the earliest.


In addition, the assessment of key secondary endpoints showed,In the group receiving the highest dose of tirzepatide, 43.0% (Study 1) and 51.5% (Study 2) of participants achieved the criteria for disease resolution.Disease elimination is defined as achieving fewer than 5 AHI events per hour, or 5-14 AHI events per hour with an Epworth Sleepiness Scale (ESS) score ≤10. The ESS is a standard questionnaire used to assess excessive daytime sleepiness.
The overall safety of tirzepatide in the SURMOUNT-OSA study was similar to that reported in previous SURMOUNT and SURPASS trials. The most commonly reported adverse events in SURMOUNT-OSA were gastrointestinal-related and generally mild to moderate.
Frequent snoring may be a sign of OSA. This condition occurs when the upper airway collapses completely or partially during sleep, leading to airway obstruction, which may cause apnea or hypoventilation, and may be accompanied by decreased oxygen saturation or waking up during sleep. OSA can trigger severe cardiometabolic complications such as hypertension, coronary artery disease, stroke, heart failure, atrial fibrillation, and type 2 diabetes. Over the past 40 years, there has been almost no significant progress in the treatment of this disease. Many patients need to use a PAP device to maintain ventilation during sleep, but such treatments have limited effectiveness, and many patients find it difficult to adapt to the discomfort caused by wearing the device.
Tirzepatide is a dual GIP/GLP-1 receptor agonist that can simultaneously activate signaling pathways mediated by both GLP-1 and GIP receptors.GIP and GLP-1 are natural incretin hormones that regulate blood glucose. Tirzepatide was approved by the U.S. FDA in May 2022 (brand name: Mounjaro) for use in conjunction with diet and exercise to improve glycemic control in adults with type 2 diabetes. In November last year, tirzepatide received another FDA approval (brand name: Zepbound) for weight loss and weight maintenance in obese or overweight adult patients.
Recently, tirzepatide also achieved positive results in the Phase 2 clinical trial SYNERGY-NASH for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) patients, and reduced the risk of heart failure-related events by 38% in obese heart failure with preserved ejection fraction (HFpEF) patients in the Phase 3 clinical trial SUMMIT.



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