EMA Supports Mounjaro Label Update for Sleep Apnea Benefits Without New Approval
核心洞察
The European Medicines Agency (EMA) will allow Eli Lilly to update Mounjaro's label to include its benefits in treating obstructive sleep apnea (搜索) (OSA) in obese patients.
Clinical data from two studies involving 469 participants showed Mounjaro improved sleep-disordered breathing, reducing irregular breathing by up to 63%.
The EMA determined a separate approval for OSA is unnecessary, as Mounjaro's existing approval for weight management sufficiently covers its benefits for OSA.
The European Medicines Agency (EMA) has permitted Eli Lilly to update the product label for its drug Mounjaro (tirzepatide) to reflect its benefits in treating obstructive sleep apnea (搜索) (OSA) in obese patients, without requiring a separate approval for this specific indication. This decision acknowledges the close relationship between obesity and OSA and the drug's demonstrated efficacy in improving sleep-disordered breathing.
EMA's Rationale
Eli Lilly sought EU approval to expand the use of Mounjaro to treat moderate to severe OSA in patients with obesity. However, the EMA concluded that a separate approval was not necessary, emphasizing the overlap between obesity and OSA. According to Lilly, approximately 58% of individuals with moderate to severe OSA are overweight.
The EMA's human medicines committee (CHMP) acknowledged that Mounjaro improves OSA in patients with obesity, determining that the drug’s existing indication for weight management sufficiently addresses its use for patients with OSA.
Clinical Trial Data
The decision is supported by data from two clinical trials involving 469 participants. These studies demonstrated that Mounjaro significantly reduced the frequency of irregular breathing in patients. Specifically, the drug helped cut the frequency of irregular breathing in patients by as much as 63% over the course of the study, as reported by Lilly in April.
Mounjaro's Mechanism and Regulatory Context
Tirzepatide, marketed as Mounjaro in Europe, is approved for treating obesity and type 2 diabetes (搜索). It functions by mimicking the actions of glucagon-like peptide-1 (搜索) (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), hormones that regulate insulin and appetite. Regulators can permit expanded use of treatments if new evidence demonstrates their effectiveness in new therapeutic areas.
Implications and Market Context
Lilly and Novo Nordisk are currently in a race to demonstrate that their obesity drugs have additional medical benefits beyond weight loss. Approval for uses beyond weight loss could significantly boost these companies, especially given the current high demand for these medications. Obstructive sleep apnea (搜索) affects approximately 1 billion people globally, according to a 2019 study published in The Lancet. Common treatments include CPAP machines, surgery, and weight loss interventions.
The EMA 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.