By Fineline Cube 
US pharma giant Eli Lilly & Co. (NYSE: LLY) announced that it has received a new market approval from China’s National Medical Products Administration (NMPA) for its drug Mounjaro (tirzepatide). The approval is for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, to be used in conjunction with dietary control and increased physical activity. Tirzepatide has demonstrated effectiveness in improving sleep disturbances in this patient population.
Clinical Trial Results
The approval was supported by results from the global, multi-center Phase III SURMOUNT-OSA study. In the study, tirzepatide significantly reduced apnea-hypopnea events per hour (AHI) by 27 events/hour in patients not using positive airway pressure (PAP) therapy (vs. 5 events/hour in placebo) and by 30 events/hour in patients using PAP therapy (vs. 6 events/hour in placebo). After one year of treatment, 43% of non-PAP users and 52% of PAP users achieved symptom resolution, far exceeding the placebo group (15% and 14%, respectively). Additionally, patients experienced average weight loss of 18.1%-20.1%.
Significance of Approval
This marks the third approved indication for tirzepatide in China, making it the first and only prescription drug approved for OSA in this patient population. This addresses a critical unmet medical need. Previously, tirzepatide was approved in China for type 2 diabetes and chronic weight management.-Fineline Info & Tech