Novo Nordisk’s Victoza gets FDA okay for paediatric use

Novo Nordisk’s GLP-1 agonist Victoza has become the first non-insulin drug to be approved in the US as a treatment for type 2 diabetes in children for almost two decades.

The FDA says the okay to use Victoza (liraglutide) in paediatric patients aged 10 or over comes “at a time when an increasing number of children are being diagnosed with this disease.” The last drug to be approved for paediatric use in type 2 diabetes was metformin back in 2000.

Type 2 diabetes is typically first diagnosed in people aged over 45, with the type 1, autoimmune form of the disease the most likely to be encountered in children. Latterly however, rising levels of overweight and obesity in even very young children has caused an uptick in type 2 cases in this age group.

The US Centers for Disease Control and Prevention estimates that more than 5,000 new cases of type 2 diabetes are diagnosed each year among in people younger than age 20 in the US, out of around 1.4 million new cases across all age ranges.

The Victoza approval comes after a priority review by the FDA, and shortly after Novo Nordisk reported the results of the phase 3 ELLIPSE trial which showed the drug was able to reduce haemoglobin A1c levels – a biomarker for blood glucose control – as effectively in children aged 10 to 17 as older patients. The GLP-1 agonist also had a similar safety profile regardless of the age of the patient.

At the time the data was announced, ELLIPSE lead investigator William Tamborlane of Yale School of Medicine said that having a GLP-1 agonist available would be “transformational”, as currently insulin is the only approved rescue therapy for children who fail metformin monotherapy. Victoza offers a second option in these cases, he added.

Victoza is Novo Nordisk’s once-daily injectable GLP-1 agonist and made around $3.6 billion in sales last year, making it the top-selling drug in the category.

It’s facing competition however from Eli Lilly’s once-weekly rival Trulicity (dulaglutide), tipped by EvaluatePharma as being likely to lead the diabetes market with sales of $5.35bn in 2024. Novo Nordisk is trying to offset with its own once-weekly drug Ozempic (semaglutide), as well as a once-daily oral formulation of semaglutide that has been filed for approval.

Novo Nordisk doesn’t mention any trials in paediatric type 2 diabetes for its new generation of GLP-1 agonists in its latest pipeline report, while Lilly is conducting a 150-patient paediatric phase 3 trial of Trulicity which is due to generate results in 2021, according to the clinicaltrials.gov database. If positive, that could provide a more patient-friendly option for children with type 2 diabetes.