European Commission adds sleep apnea use to Mounjaro's EU label
Mounjaro's European label now covers obstructive sleep apnea in adults with obesity, a change that does not by itself alter US prescribing or insurance coverage.
The European Commission adopted a change to Mounjaro's European Union labeling on February 14, 2025 that adds obstructive sleep apnea as an approved use, according to the European Medicines Agency's record of procedural steps for the product [1]. The decision covers variation II/0027 and follows the agency's opinion on the same change, issued December 12, 2024 [1].
Mounjaro is the brand name for tirzepatide, a once-weekly injected medicine. The variation updates sections 4.1, 4.8 and 5.1 of the Summary of Product Characteristics, the document that sets out a medicine's approved uses, side effects and pharmacology in the EU [1]. The package leaflet was updated to match [1].
The agency's record describes the evidence behind the change as two studies, IBF-MC-GPI1 and IBF-MC-GPI2. Both are listed as multicentre, randomized, parallel-arm, double-blind, placebo-controlled studies investigating the effects of tirzepatide compared with placebo in adult participants with moderate-to-severe obstructive sleep apnea and obesity [1].
The results of those two trials are not included in this record. How much the medicine changed sleep apnea severity, how much weight participants lost, how many people were enrolled and how long they were followed are all not reported here. The agency points to a separate document, the scientific discussion labeled "Mounjaro-H-C-005620-II-0027," for those details [1].
The February 14, 2025 decision date also appears against several other Mounjaro variations [1]. These include a periodic safety update for tirzepatide, which received an opinion on December 12, 2024, and a safety and efficacy variation numbered IAIN/0035, which received an opinion on October 2, 2024 [1]. Those items are listed as affecting the Summary of Product Characteristics and package leaflet [1].
Mounjaro has held an EU indication for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in adults with obesity or overweight plus at least one weight-related condition, since a Commission decision on December 11, 2023 [1]. The EU authorization also includes six single-dose strengths from 2.5 mg to 15 mg for the pre-filled pen, added by a Commission decision on April 19, 2024 [1].
Why it matters for patients
Obstructive sleep apnea and obesity frequently occur together, and tirzepatide is already prescribed for weight management and for type 2 diabetes. A labeling change in Europe means doctors there can now prescribe it for the sleep apnea population described in the two trials, rather than only for weight or diabetes. The EU record does not say whether the medicine is meant to replace or accompany existing sleep apnea treatments such as CPAP machines, and no guidance on that is included [1].
This decision applies to the European Union. It does not change how Mounjaro is prescribed in the United States, and no US regulatory action on a sleep apnea indication for tirzepatide is described in this record [1]. Insurance coverage decisions in the US are separate from EU labeling and have not been reported here. The record also does not state whether the new EU indication carries restrictions, such as a required sleep apnea severity or a body mass index threshold [1].
What happens next
The agency's public record says further detail is contained in the scientific discussion document for variation II/0027, which is referenced but not included [1]. No dates for additional steps on this indication, in Europe or elsewhere, are given in the record [1].
Sources
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