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Novo Nordisk's GLP-1 agonist, Victoza, is the first non-insulin drug approved in the United States for the treatment of type 2 diabetes in children for almost two decades.
The FDA approves the use of Victoza (liraglutide) in pediatric patients aged 10 years and older "at a time when a growing number of children are diagnosed with this disease". The last drug approved for pediatric use in type 2 diabetes was metformin in 2000.
Type 2 diabetes is generally diagnosed for the first time in people over the age of 45, the type 1 autoimmune form being the most likely disease in children. Recently, however, the increase in overweight and obesity among even very young children has resulted in a slight increase in the number of 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 every year in the United States under the age of 20, out of an estimated 1.4 million new cases in all age groups.
Victoza approval comes after FDA priority review and soon after Novo Nordisk reported on results of Phase 3 trial ELLIPSE, which showed the drug was able to reduce hemoglobin levels A1c – a biomarker for the control of blood glucose – effectively in children 10 to 17 years old in older patients. The agonist of GLP-1 also had a similar safety profile, regardless of the patient's age.
At the time of the announcement of the data, William Tamborlane, principal investigator of ELLIPSE, of the Yale School of Medicine, had stated that having an available GLP-1 agonist would be "transformational" because the Insulin is currently the only approved life-saving treatment for children who fail with monformamine. Victoza offers a second option in these cases, he added.
Victoza is the once-daily injectable GLP-1 agonist of Novo Nordisk. It had sales of nearly $ 3.6 billion last year, making it the best-selling drug in the category.
However, he faces competition from his weekly rival Eli Lilly, Trulicity (dulaglutide), presumed by EvaluatePharma as likely to dominate the diabetes market with sales of $ 5.35 billion in 2024. Novo Nordisk is trying to compensate with its Ozempic's own weekly medication (semaglutide), as well as an oral formulation of semaglutide to be administered once a day, which was filed for approval.
Novo Nordisk does not mention any pediatric type 2 diabetes trial for its new generation of GLP-1 agonists in its latest report underway, while Lilly conducts a Trulicity pediatric phase 3 trial on 150 patients, which should produce results in 2021., according to the teclinique.gov database. If the result is positive, it may be a more user-friendly option for children with type 2 diabetes.
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