CHMP Recommends Extension to Victoza Indication for Treatment of Pediatric Type 2 Diabetes

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that the indication of Victoza (liraglutide) be extended to include its use in pediatric patients with Type 2 diabetes.

Victoza is already indicated for the treatment of Type 2 diabetes in adults alongside a program of diet and exercise. It is currently used either as a standalone treatment or in combination with other diabetes medicines.

Recommended treatment pathways for pediatric Type 2 diabetes is similar to that of adults-an emphasis is placed upon a step-wise approach, initially with lifestyle modifications, followed by the use of a single medical therapy and latterly two therapies in combination. Only two treatment options are available for use in pediatric Type 2 patients in most countries-metformin and insulin-however, it is not always possible to achieve glycemic control with the currently available options and as such, a medical need for alternative options for the patient group has been cited.

Victoza is an ‘incretin mimetic’, which means that it acts in the same way as a group of metabolic hormones that stimulate an increase in the amount of insulin released by the pancreas as a result of the ingestion of food. The therapy’s efficacy and safety have been investigated in a placebo-controlled trial with 134 pediatric patients (aged 10–17 years). The results of the study demonstrated a comparable safety profile of that when the therapy is used in adult patients.

The positive opinion adopted by CHMP on Victoza is an intermediary step on the therapy’s path to becoming accessible by patients in the new indication. The recommendation will be put forward to the European Commission for decision on an EU-wide marketing authorization. 

Source: EMA