Lilly's Tirzepatide Gains New NMPA Approval for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity

Today (July 3), the official website of China's National Medical Products Administration (NMPA) announced that Eli Lilly's Mounjaro (tirzepatide injection) has been approved for a new indication in China.For the treatment of moderate to severe obstructive sleep apnea (OSA) in adult patients with obesityTirzepatide can improve sleep disorders in obese adult patients with moderate to severe obstructive sleep apnea. The use of this indication should be based on dietary control and increased exercise. ——Eli Lilly and CompanyThe press release stated,Adult patients treated with tirzepatide experienced an average weight loss of 20% and a reduction of at least 27 episodes of apnea-hypopnea per hour of sleep; more than half of the patients no longer had OSA-related symptoms after one year of treatment with tirzepatide.。

Obstructive sleep apnea is a common type of sleep-related breathing disorder characterized by complete or partial collapse of the upper airway during sleep, leading to apnea or hypoventilation, accompanied by decreased blood oxygen saturation and/or micro-arousals. Patients primarily present with clinical symptoms such as snoring during sleep accompanied by apnea, daytime sleepiness, non-restorative sleep, fatigue, and insomnia. Moreover, it is associated with traffic and occupational accidents, cardiovascular diseases, neurological disorders, metabolic conditions, cancer, immune system diseases, and an increased risk of all-cause mortality. Public data shows,OSA is a highly prevalent disease, and its treatment mainly focuses on lifestyle interventions and device therapy. However, these methods may not address certain risk factors associated with OSA, such as obesity.。

Tirzepatide is a dual receptor agonist drug for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). Tirzepatide acts on the root causes of obesity, reducing appetite and food intake.Previously, tirzepatide has been approved by the NMPA for use in: patients whose blood glucose remains poorly controlled despite treatment with metformin and/or sulfonylureas, in addition to diet control and exercise.Adult Type 2 DiabetesPatients: On the basis of controlling diet and increasing exercise, the initial Body Mass Index (BMI) meets the following requirementsLong-term Weight Management in Adults: ≥28 kg/㎡ (Obesity), or ≥24 kg/㎡(Overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, hyperglycemia, obstructive sleep apnea, cardiovascular disease, etc.).

This approval is mainly based on the results of the Phase 3 clinical trial, SURMOUNT-OSA. The one-year trial evaluated the efficacy of tirzepatide (10mg or 15mg) in treating moderate to severe obstructive sleep apnea in adult obese patients who are either receiving or unwilling to receive positive airway pressure (PAP) therapy. In adult patients not using PAP therapy, tirzepatide was five times more effective than placebo in reducing apnea-hypopnea events.That is, tirzepatide can reduce the number of apnea-hypopnea episodes per hour by 27 times., while the placebo only reduced 5 times. In adults using PAP treatment,Tirzepatide Reduces Apnea-Hypopnea Index by 30 Episodes Per Hour, while the placebo only reduced it by 6 times. After one year of treatment, 43% of adult patients using tirzepatide alone achieved complete remission of OSA symptoms or a mild OSA status with no symptoms, whileIn patients receiving both tirzepatide and PAP treatment, this proportion was 52%.; The figures for the placebo group were 15% and 14%, respectively.

In addition to improving OSA symptoms, adult patients receiving tirzepatide treatment experienced an average weight loss of 18.1%.Adult patients receiving both tirzepatide and PAP treatment experienced an average weight loss of 20.1%.; while in the placebo group, adult patients experienced an average weight loss of 1.3% and 2.3%, respectively. The safety and tolerability of tirzepatide were consistent with the safety profile reported in previous trials. The most common adverse events were gastrointestinal adverse events, which were mild to moderate in severity.