EU regulators extend Mounjaro use to children as young as 10 with type 2 diabetes

The European Medicines Agency has recommended extending the use of tirzepatide, sold as Mounjaro, to children as young as 10 years old who have type 2 diabetes, in addition to a reduced-calorie diet and increased physical activity. The decision marks a shift in pediatric treatment options, which up to now largely revolved around metformin and insulin for this aggressive form of diabetes in youth. Mounjaro, a glucagon-like peptide-1 (GLP-1) agonist, is already approved in Europe for adults for both weight loss and uncontrolled type 2 diabetes and is now poised to join those indications for younger patients under the EMA’s guidance. The drug works by mimicking gut hormones that regulate blood sugar, suppressing appetite, slowing digestion and lowering glucose levels.

To qualify for treatment, adults in the current approvals must meet obesity criteria or have a BMI between 27 and 30 with at least one weight-related condition. For children, the EMA’s proposal would allow use in patients aged 10 and older with type 2 diabetes, potentially as a stand-alone therapy or as an add-on to other diabetes medicines, guided by clinicians on a case-by-case basis. In adults, Mounjaro’s approvals have been accompanied by a recognition that a range of GLP-1 drugs is available on the NHS for weight management or diabetes, though those drugs are primarily recommended for adults at present.

In a late-stage trial published in The Lancet, researchers studied children aged 10 to 17 with type 2 diabetes who received tirzepatide over a 52-week period. The results showed that the medication not only improved glycemic control but also produced notable weight loss. By 30 weeks, participants on the 10 mg dose experienced meaningful reductions in body-mass index, averaging an 11.2 percent decrease. Pediatric type 2 diabetes can be more aggressive than the adult form, with risks of long-term organ damage if not effectively controlled. The EMA’s recommendation reflects a view that extending access to Mounjaro could help alter the longer-term health trajectory for young patients confronting this condition.

As with adults, some children in the pediatric trial experienced adverse effects, including diarrhea, nausea, vomiting and abdominal pain. Researchers noted that these side effects were in line with the known safety profile observed in adult studies, and relatively few participants stopped treatment due to these events. Lead author Dr. Tamara Hannon, director of the Clinical Diabetes Programme at Indiana University School of Medicine, emphasized the severity of type 2 diabetes in youth and the potential for Mounjaro to offer a meaningful treatment option when first-line therapies such as metformin and insulin fail to achieve adequate control. “Youth living with type 2 diabetes often face a more aggressive disease course,” Hannon said. “These results offer a promising opportunity to help shift the long-term health trajectory for young people living with this complex condition.”

The EMA decision comes amid broader concerns about child obesity and diabetes risk in Europe and elsewhere. In the United Kingdom, NHS data analyzed by public health researchers show rising rates of obesity among children, with data indicating a substantial portion of primary school pupils are overweight or obese and that obesity trends in children remain higher than pre-pandemic levels. The most recent figures also show that a large share of the child population is at risk for weight-related health problems as they grow older. Experts say that the emergence of pediatric type 2 diabetes—already a small but growing concern— underscores the need for effective, long-term treatment strategies that address both blood sugar control and weight management.

The move also aligns with a broader industry pattern, as several GLP-1 therapies have already been approved for pediatric use in some markets. Novo Nordisk, for example, has had its own GLP-1–based treatments cleared for use in children aged 12 and older in certain contexts. The EMA’s recommendation to extend Mounjaro to 10-year-olds could influence regulatory and clinical guidance across Europe, potentially shaping future practice in pediatric diabetes care while continuing to be considered alongside ongoing lifestyle interventions.

If adopted by EU member states, the expanded indication could expand access to tirzepatide for younger patients grappling with type 2 diabetes and associated weight concerns. Regulators will weigh the benefits of improved glycemic outcomes and weight loss against the need for careful monitoring of adverse effects in a younger population. Clinicians say any such extension should be implemented with close patient selection, individualized dosing, and ongoing surveillance for safety and tolerability, particularly as pediatric data accumulate and long-term outcomes become clearer.