CHMP refuses an EU heart failure indication but accepts the SUMMIT data into the label

The European Medicines Agency has finished reviewing Eli Lilly's request to expand Mounjaro (tirzepatide) to treat symptomatic chronic heart failure with preserved ejection fraction (HFpEF) in adults with obesity. In a document dated 30 January 2026, the agency said it did not recommend granting a separate HFpEF indication, but agreed to add data from the supporting study to the medicine's product information ^[1].

The application was filed as variation EMEA/H/C/005620/II/38 ^[1]. Mounjaro has been authorised in the EU since September 2022 and is currently approved there for type 2 diabetes in adults, adolescents and children aged 10 and above, and for weight management in adults with a BMI of 30 kg/m² or more, or 27 to under 30 kg/m² with at least one weight-related condition ^[1][2].

What the study showed

The company submitted a main study in 731 adults with obesity and chronic HFpEF who received either tirzepatide or placebo ^[1]. The main effectiveness measures were change in heart failure symptoms and their effect on daily life, scored with the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) after 52 weeks, plus the number of deaths from heart and circulation problems or episodes of worsening heart failure. Worsening events included hospitalisations for heart failure, urgent heart failure visits, and stepping up diuretic treatment ^[1].

The EMA's read of the results was mixed. The agency acknowledged that tirzepatide did not reduce deaths from heart and circulation problems in this group, but did significantly reduce heart failure hospitalisations and improved patients' quality of life ^[1]. The EMA document does not give the size of those effects in numbers.

The refusal rested on two points. First, the agency said uncertainty remains about whether the benefits are an effect of tirzepatide independent of weight loss ^[1]. Second, it concluded that use in these patients is already covered by the approved weight-management indication, so "a separate indication for the treatment of adults with chronic HFpEF and obesity is not needed" ^[1]. Obesity is described in the same document as an established risk factor for heart failure, and the agency noted that losing excess body weight can improve chronic HFpEF symptoms ^[1].

Instead of a new indication, the prescribing information is being updated so that health professionals can see the data ^[1]. The EU summary of product characteristics already points readers from the weight-management indication to section 5.1 for trial results on both obstructive sleep apnoea and HFpEF ^[2].

The EMA also said the company reported no consequences for patients in ongoing Mounjaro clinical trials ^[1].

Why it matters for patients

For people in Europe, the practical effect is narrow: nothing changes about who can be prescribed Mounjaro. Patients with obesity and HFpEF who already qualify under the weight-management criteria remain eligible under that indication, and the dosing in the EU label is unchanged, with a 2.5 mg weekly start, maintenance doses of 5, 10 and 15 mg, and a 15 mg weekly maximum in adults ^[2].

For US readers, this is a European decision and does not change FDA labeling. What it does show is how a regulator weighed the same evidence: hospitalisations and symptom scores moved, deaths did not, and the agency could not separate the heart benefit from the weight loss itself ^[1]. That distinction matters in debates over insurance coverage, because payers often key off specific approved indications rather than general trial findings.

The EMA document does not name the trial, describe how much KCCQ-CSS scores improved, or give hospitalisation rates, and it does not address the status of any US application for the same use. Those details are not available in the documents released with this decision.

What happens next

The EMA published the outcome on 30 January 2026 ^[1]. The next visible step is the updated Mounjaro product information carrying the HFpEF study results in section 5.1 ^[1][2]. No timeline for a resubmission or a new application has been announced in these documents.