Mounjaro Approved for Pediatric Type 2 Diabetes in the EU

The European Medicines Agency (EMA) has granted approval to extend the permitted uses of Mounjaro (tirzepatide, Eli Lilly Nederland B.V.). This expansion allows its application in treating type 2 diabetes in children and adolescents, aged 10 and older, when their condition is not adequately managed.

Currently, the drug is approved alongside diet and exercise for adults with type 2 diabetes that isn't well-controlled. It can be used alone if patients can't take metformin or as an addition to other diabetes medications. Health tracking apps like Shotlee can help monitor blood glucose levels.

It's also approved for those with obesity (BMI ≥ 30) or who are overweight (BMI 27-30) with at least one weight-related health issue. This includes conditions like hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus. Tirzepatide is designed to aid in weight loss and maintenance.

Extension to Children

The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended extending tirzepatide's use to children. This would be in conjunction with a reduced-calorie diet and increased physical activity for managing weight.

Tirzepatide, a prescription medication, functions as both a GLP-1 agonist and a glucose-dependent insulinotropic polypeptide agonist. This dual action boosts insulin secretion, lowers blood sugar, regulates appetite, slows gastric emptying, and manages fat metabolism.

The drug is available as a solution for injection in prefilled pens. It’s administered subcutaneously once a week into the abdomen, upper arm, or thigh.

Long Term Glucose Control

Prior research involving over 6000 adults with type 2 diabetes demonstrated tirzepatide's effectiveness in managing blood glucose. This was shown through reductions in A1c, a measure of long-term glucose control. Studies revealed A1c reductions between 2.1 and 2.6 percentage points after 40-52 weeks when combined with existing treatments and/or lifestyle changes.

In comparison, the placebo groups showed A1c reductions between 0 and 0.9 percentage points, while those on comparative treatments experienced reductions of 1.3 to 1.9 percentage points.

Regarding weight management, studies on over 2500 adults with obesity or overweight and at least one weight-related comorbidity showed that tirzepatide, at varying doses combined with diet and exercise for 72 weeks, reduced weight by at least 15% on average. Conversely, the placebo group had an average weight loss of only 3%. The CHMP noted that over 85% of people taking tirzepatide reduced their weight by at least 5%, compared to 35% on placebo. Weight loss primarily resulted from a reduction in fat mass and correlated with improvements in other measures like hypertension and hyperlipidemia.

Similar Safety Profile to Adults

A phase 3 trial of tirzepatide in children and adolescents with type 2 diabetes, with results published in The Lancet in October, indicated that the drug met the primary and all key secondary endpoints at 30 weeks. It also demonstrated sustained improvement in glycemic control and continued BMI reduction throughout the study's 52-week extension. A1c was reduced by an average of 2.23% in the tirzepatide group, compared to an increase of 0.05% in the placebo group. The safety and tolerability of the drug in children were generally consistent with previous studies in adults.

In adult studies, the most frequent side effects of tirzepatide have been gastrointestinal, including nausea, diarrhea, constipation, and vomiting.

The full approved use for tirzepatide is now: for treating adults, adolescents, and children aged 10 and older with inadequately controlled type 2 diabetes mellitus as an addition to diet and exercise; as a standalone treatment when metformin is unsuitable due to intolerance or contraindications; or in conjunction with other medications for diabetes treatment.