The EMA has determined that Mounjaro’s existing weight management approval includes its benefits for treating obstructive sleep apnea, eliminating the need for a separate application for an OSA indication.
RT’s Three Key Takeaways:
- No Separate Indication Needed: The European Medicines Agency (EMA) has determined that Eli Lilly’s Mounjaro (tirzepatide), approved for weight management, does not require a separate indication for treating obstructive sleep apnea (OSA) in adults with obesity.
- Clinical Data Reviewed: Clinical data from two studies showed Mounjaro improves OSA symptoms by reducing weight. However, the EMA concluded these benefits are already covered under its existing approval for obesity treatment.
- Updated Product Information: Relevant data will be added to the product information, ensuring healthcare professionals are informed about Mounjaro’s effects on OSA in obese patients.
The European Medicines Agency (EMA) has determined that Eli Lilly’s Mounjaro’s existing approval for weight management already encompasses its benefits for obstructive sleep apnea (OSA) in adults with obesity, making a separate indication unnecessary.
Eli Lilly sought approval to extend its use specifically to moderate-to-severe cases of OSA in obese adults.
Mounjaro (tirzepatide), approved in the European Union since September 2022, is used to treat type 2 diabetes and assist with weight loss by mimicking the hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which regulate insulin and appetite. Given the established relationship between obesity and obstructive sleep apnea, weight reduction can improve symptoms of the condition.
To support the application, the company submitted data from two clinical studies involving 469 adults with moderate-to-severe sleep apnea and obesity. These studies compared Mounjaro to a placebo, focusing on changes in the apnea-hypopnea index over one year. The results demonstrated improvements in sleep-disordered breathing in patients treated with Mounjaro.
The EMA’s human medicines committee (CHMP) acknowledged that Mounjaro improves OSA in patients with obesity. But it concluded that the drug’s existing indication for weight management sufficiently addresses its use for patients with OSA.
EMA says it will include relevant data submitted with the application in the medicine’s product information to ensure healthcare professionals have access to the latest data on the effects of Mounjaro in patients with OSA and obesity.
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