EMA backs extending Mounjaro to children with type-2 diabetes
On 11 December 2025 the EMA's CHMP recommended extending Mounjaro's licensed indication to adolescents and children aged 10 and over with insufficiently controlled type-2 diabetes.
Why we wrote this. Paediatric T2D coverage is the single area where European regulators move faster than the FDA on incretin drugs. We want readers to see that timing.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended on 11 December 2025 that tirzepatide, marketed in the EU as Mounjaro by Eli Lilly Nederland, be authorised for use in adolescents and children aged 10 and over with type-2 diabetes that is not adequately controlled on existing therapy.
If the European Commission ratifies the opinion in the usual two-month window, the updated label will read: "Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus." The recommendation rests on the SURPASS-PEDS programme data and builds on the existing adult authorisations across the EU and EEA.
What changes for prescribers
Today the EMA's authorisation covers adults only. National medicines agencies in the seven jurisdictions PeptideMethods tracks all reflect that adult-only status on our regulation pages. A confirmed paediatric label is the first time a dual GIP and GLP-1 receptor agonist will be available for under-18s in the EU, and it brings tirzepatide into the same paediatric T2D space already occupied by metformin and insulin.
The CHMP opinion does not change the existing adult licence or the obesity indication. Mounjaro for chronic weight management remains a separate authorisation; this recommendation is for the type-2 diabetes indication only.
How to read the timing
The EMA paediatric extension lands at the same moment that a wave of Phase 3 readouts is reshaping the entire incretin class. The TRIUMPH-1 obesity Phase 3 trial of retatrutide reported 28.3% mean weight loss at 80 weeks five days earlier, and SURMOUNT-5 head-to-head data against semaglutide continues to favour tirzepatide on weight outcomes. The paediatric move locks in the leading dual agonist in a setting where the competition is light.
What is not in the recommendation
No paediatric weight-management approval. No change to the boxed warning on thyroid C-cell tumours (medullary thyroid carcinoma and MEN-2 remain contraindications). No change to the price or the reimbursement criteria that countries apply nationally. Per-country detail on those criteria is on our regulation pages.
Where this lands on the site
Coverage will refresh: the tirzepatide news ticker on the main page logs the CHMP opinion; the per-country regulation pages will update as each national agency reflects the paediatric extension; and the December 2025 EMA decision becomes part of the timeline.
Frequently asked
Is Mounjaro now approved for children with type-2 diabetes in the EU?
The CHMP issued a positive opinion on 11 December 2025 recommending extension to adolescents and children aged 10 and over. Final authorisation comes from the European Commission shortly afterwards. Member state agencies update national pricing and reimbursement separately.
Does this change anything for adults already on Mounjaro?
No. The adult type-2 diabetes and weight-management indications are unchanged. The recommendation only adds adolescents and children aged 10 and over with type-2 diabetes to the existing label.
What about the US?
The FDA approved Mounjaro for type-2 diabetes in adults in May 2022 and Zepbound (same molecule, weight indication) in November 2023. There is no current paediatric T2D approval for tirzepatide in the US; Eli Lilly has not publicly confirmed an FDA paediatric filing timeline as of this writing.