European committee backs Mounjaro for children 10 and older with type 2 diabetes

Europe's medicines regulator moved a step closer to allowing Mounjaro to be used in younger children. On Friday, Dec. 12, a committee of the European Medicines Agency recommended extending the use of Eli Lilly's type 2 diabetes drug to adolescents and children aged 10 and older ^[1].

The drug is tirzepatide, sold as Mounjaro in Europe ^[1]. It is already approved there for adults whose type 2 diabetes is not satisfactorily controlled, and for weight loss in adults ^[1].

Under the recommendation, Mounjaro could be used in people older than 10 who have insufficiently controlled type 2 diabetes. It could be given on its own when metformin is considered inappropriate because of intolerance or contraindications, or as an add-on to other diabetes medicines ^[1].

Until now, treatment options for children with type 2 diabetes to control blood sugar had been limited to metformin and insulin ^[1]. Novo Nordisk's older GLP-1 drug, Victoza, is already approved for children 10 and older with type 2 diabetes, and Novo's Wegovy is used to help children aged 12 and older with weight loss ^[1]. Lilly and Novo Nordisk have both been studying their blockbuster GLP-1 drugs in younger patients ^[1].

In a late-stage trial, Mounjaro helped children and adolescents aged 10 to 17 with type 2 diabetes manage their blood sugar better and lose weight ^[1]. The size of the blood sugar improvement and the amount of weight lost, and how those results compared with other treatments, have not been reported ^[1].

Why it matters for patients

Children with type 2 diabetes have had a very short list of drug options — metformin and insulin ^[1]. The recommendation, if finalized, would add a drug from a newer class, known as GLP-1 medicines, to that list in Europe. Mounjaro's active ingredient, tirzepatide, works differently from metformin and insulin ^[1].

The recommendation covers the type 2 diabetes indication only. Mounjaro's weight-loss approval in Europe is for adults, and nothing in the Dec. 12 recommendation extends a weight-loss use to children ^[1]. That distinction matters for families who may hear about the drug as a weight-loss treatment.

The recommendation applies in Europe. Whether a similar change applies in the United States, and on what timeline, has not been reported ^[1].

The recommendation also sets conditions on when the drug would be used in children: alone only when metformin is not appropriate because of intolerance or contraindications, or alongside other diabetes medicines ^[1]. Any decision about a specific child's treatment would be made by that child's clinician.

What happens next

A committee recommendation is not a final approval, and it has not been reported when a final decision on the European labeling change will be made ^[1].

Lilly and Novo Nordisk have continued testing their GLP-1 drugs in younger patients, but no further results or filing dates were disclosed ^[1].

It also has not been reported what the recommendation means for pricing, insurance coverage or how quickly the drug would reach children in European countries if the change takes effect ^[1].