EU regulators move to add SURPASS-CVOT heart data to Mounjaro label

European regulators have moved to add final results from the SURPASS-CVOT cardiovascular trial to the European product information for Mounjaro (tirzepatide), according to the European Medicines Agency's procedural record for the drug ^[1].

The change was filed as a type II variation, EMA/VR/0000310637, with an opinion issued on 25 June 2026 ^[1]. It updates sections 4.1, 4.4, 4.8 and 5.1 of the Summary of Product Characteristics and the package leaflet based on final results from study I8F-MC-GPGN (SURPASS-CVOT) ^[1]. The company also submitted version 10.1 of its risk management plan ^[1].

SURPASS-CVOT was a Phase 3, event-driven, multicentre, international, randomised, double-blind, active-comparator, parallel-group study. It assessed the effect of tirzepatide versus dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes ^[1].

The procedural record describes the study design and lists which label sections changed. It does not include the trial's numerical results — no hazard ratios, event rates or participant counts. Those figures have not been reported in this document ^[1], so how the two drugs compared on heart attacks, strokes or cardiovascular death is not yet known from it.

The 25 June 2026 date is an opinion, not the final step. The record shows no Commission Decision date for this variation yet ^[1]. Under EU rules, a Commission decision is issued within two months of the opinion for variations of this type, or within one year for other procedures, and the product information is amended at that point ^[1].

The same record lists other recent EU label changes for Mounjaro. A variation decided on 22 January 2026 extended the indication to include children and adolescents aged 10 years and older with type 2 diabetes inadequately controlled with metformin, basal insulin, or both, based on final results from study I8F-MC-GPGV (SURPASS-PEDS); that update covered SmPC sections 4.1, 4.2, 4.8, 5.1, 5.2 and 5.3 and version 7.1 of the risk management plan ^[1].

A separate update to section 4.6, on breast-feeding, followed the GPIN lactation study. It reports that after a single 5 mg dose, the concentration of tirzepatide in breastmilk was undetectable to very low compared with plasma concentrations, and that because tirzepatide is an amino acid sequence, any low amount present is expected to be degraded and not orally absorbed as intact drug by a breastfed infant ^[1]. That change states tirzepatide could be considered for use during breast-feeding, and also notes the possibility that the mother's use could indirectly affect the infant through altered breast milk composition in response to reduced maternal food intake ^[1].

Why it matters for patients

The update applies to the European product information for Mounjaro, not to US prescribing information ^[1]. US labels are set separately by the FDA, and the European record does not state whether the agency has made a matching change based on the same trial data ^[1].

For anyone in the US trying to judge what SURPASS-CVOT showed, this procedural document is not a usable source: it names the trial and the label sections affected, but leaves out the results ^[1]. It shows that European regulators reviewed the cardiovascular outcomes data and decided the label should reflect them in the sections prescribers consult for indications, warnings, side effects and pharmacology ^[1]. It does not show the size or direction of any effect on heart risk.

People who want to read the actual claim will have to wait for the revised European Summary of Product Characteristics and its scientific discussion, or for a US label change, if one comes ^[1].

What happens next

The next step is a Commission Decision formally amending the marketing authorisation. The record gives no date; under EU rules a decision comes within two months of the 25 June 2026 opinion for this type of variation, or within one year for other procedures ^[1].

Once that decision is issued, the revised Summary of Product Characteristics, Annex II and package leaflet are published ^[1]. The EMA points to a separate scientific discussion document, "Mounjaro-H-C-005620-II-EMA/VR/0000310637", for more information, but the record does not say when it will appear or what figures it will contain ^[1].