The number of children with type 2 diabetes is increasing, but it still took almost 10 years to get Victoza approved for youngsters after it was already OK’d for adults.
Type 2 diabetes is becoming more common among children, but they now have a new tool to help control it.
The drug is expected to help a relatively small but growing group of children and teens who have limited treatment options.
The approval could also be an indication that drug companies and the FDA are increasing their attention on this growing problem.
The drug, Victoza, works by mimicking a protein that’s insufficient in people with type 2 diabetes.
With the drug, their pancreases should be able to make the right amount of insulin to improve blood sugar levels.
Victoza was approved for use by adults in 2010. But, its manufacturer said, problems with finding enough young participants for a clinical trial led to long delays in being able to get approval for its use in minors.
That underlines a problem facing children with type 2 diabetes, said Michael Bachner, spokesperson for the diabetes unit of Novo Nordisk, which makes Victoza.
“The main challenge is around recruiting, because the population is so small,” Bachner told Healthline.
He said the FDA typically requires companies to evaluate whether newly approved drugs should undergo a clinical trial for use in children.
But for Victoza, the clinical trial of pediatric patients took nearly 10 years, including nearly 6 years of recruiting participants, Bachner said.
Part of the problem is the relatively small number of children who would benefit from the expanded approval for the drug.
Bachner said Victoza is for 10- to 17-year-olds with type 2 diabetes. He estimated there are 20,000 to 25,000 of them in the United States.
But that number is growing.
People with type 2 diabetes are unable to properly use insulin to regulate blood sugar levels, while those with type 1 don’t produce enough of it.
Either way, blood sugar builds up.
Once known as juvenile diabetes, type 1 diabetes is commonly diagnosed in childhood. But rates of type 2 are on the rise among kids.
About 1 in 10 people in the United States have type 2 diabetes, most of them over age 45.
But as childhood obesity becomes more common, so is childhood type 2 diabetes.
The number of children with the disease increased nearly 5 percent from 2002 to 2012, according to the
“This is a population that is small but growing,” Bachner said.
Victoza is the first non-insulin drug approved for youth.
An FDA spokesperson told Healthline that the approval for expanding Victoza to be used by pediatric patients “was based on the efficacy and safety in a trial with 134 pediatric patients 10 years and older for more than 26 weeks.”
She said she couldn’t comment whether other drugs to help children with type 2 diabetes may be pending.
Bachner also couldn’t speak to whether Novo Nordisk had future plans for more drugs for children with type 2 diabetes. But he said he’d just been in a meeting with other employees where people “had talked about how monumental of a milestone this is for patients.”
“This is a population that has long been in need of something,” he said.
FDA approval for an existing drug to be used by children with type 2 diabetes offers a new treatment to this small but growing population.
Typically a disease that afflicts older adults, the number of children with type 2 diabetes has been increasing in recent decades.
The drug, Victoza, gives them a new non-insulin-based option to help regulate their blood sugar.