EU regulator moves to add Mounjaro head-to-head semaglutide data to label

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended on Oct. 23, 2025, that results from SURMOUNT-5 be added to the European Union's prescribing information for Mounjaro (tirzepatide). SURMOUNT-5 compared tirzepatide head-to-head with semaglutide, and the findings would enter section 5.1 of the EU summary of product characteristics, the section that lays out a medicine's clinical trial data ^[1].

Section 5.1 covers pharmacodynamic properties. EMA procedural records for Mounjaro show that updates to that section based on new trial results go through type II variations — formally described as "change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new quality, preclinical, clinical or pharmacovigilance data" ^[1]. One such accepted variation updated sections 4.1, 4.4, 4.8 and 5.1 with final results from SURPASS-CVOT, a phase 3, event-driven, multicentre, international, randomised, double-blind, active-comparator, parallel-group study that compared tirzepatide with dulaglutide for major adverse cardiovascular events in people with type 2 diabetes ^[1]. That procedure also updated the package leaflet and submitted a new version of the risk management plan ^[1].

A committee opinion is a recommendation, not a final decision. For variations that change the terms of a marketing authorisation, the European Commission issues its decision within two months for procedures falling under Article 23.1a(a) of Regulation (EU) No 712/2012, or within one year for other procedures ^[1]. The procedural record does not state which timeline applies to this change, and it does not give the SURMOUNT-5 results, the number of participants, or the wording added to section 5.1.

The same record lists other recent changes to Mounjaro's EU product information. Breastfeeding guidance was revised after the GPIN lactation study, a phase 1, single-site, open-label, single-treatment-arm study that measured tirzepatide in breastmilk and plasma in healthy lactating women after a single 5 mg dose; the concentration in breastmilk was undetectable to very low compared with plasma concentrations ^[1]. Separately, the indication was extended to children aged 10 years and older with type 2 diabetes based on final results from SURPASS-PEDS ^[1]. Those changes are not the same as the SURMOUNT-5 addition.

Why it matters for patients

This is a European Union label change, not a US one. Prescribing information in the United States is set by the Food and Drug Administration, and whether that agency will add SURMOUNT-5 results to US labeling for Mounjaro or Zepbound has not been reported. US prescriptions, formularies and coverage are not affected by a CHMP recommendation.

Adding trial data to section 5.1 also does not widen what the drug is approved to treat. Section 5.1 is where regulators describe study results; approved uses appear in section 4.1 ^[1]. A change of this kind alters what a clinician or pharmacist can read in the official product information, and it means regulators have reviewed the head-to-head data before it appears there.

For people weighing tirzepatide against semaglutide, a direct comparison carried in an official label is a notable reference point, because it has gone through regulatory review rather than being reported only at a conference or in a journal. The specific numbers that European patients and clinicians will see have not been disclosed in the procedural record, so it is not yet known how the two drugs compare in the label text.

What happens next

A European Commission decision on the label change is expected within two months or up to one year after the committee opinion, depending on which procedure type applies ^[1]. Whether the FDA takes a similar step in the US has not been announced.