A small but rapidly growing number of U.S. adolescents began treatment with Novo Nordisk's weight-loss drug Wegovy last year, a powerful new tool to address record rates of pediatric obesity, according to data shared exclusively with Reuters.

In the first 10 months of 2023, 1,268 children ages 12 to 17 with an obesity diagnosis started taking Wegovy, according to U.S. insurance claims data compiled by health technology company Komodo Health.

In 2022, only 25 children were prescribed the drug, which did not receive U.S. approval for adolescent use until December of that year. A month later, the influential American Academy of Pediatrics recommended weight-loss drugs be offered to children with obesity starting at age 12.

Medicaid data obtained by Reuters from five states, including Michigan, Minnesota and Wisconsin, show a similar uptick in use of Wegovy. The overall numbers remain small, with at least 464 children across the five states being prescribed the drug since January 2022.

That does not include prescriptions bought without health insurance, or off-label use of two similar treatments for type 2 diabetes, Ozempic from Novo and Mounjaro from Eli Lilly.

Even so, they are a drop in the bucket as nearly 20% of U.S. children, or about 14.7 million, have obesity, according to federal estimates.

But the data indicate an increasing willingness among families to embrace Wegovy, the first highly effective treatment for obesity, short of surgery. Use of the weekly injection can involve great cost, with limited data on long-term risks and benefits.

"I use these medications wherever I can. Unlike with adults, where it’s like a rescue operation, we are much more likely with children and adolescents to prevent disease," said Dr. Suzanne Cuda, medical director of Alamo City Healthy Kids and Families in San Antonio, Texas. Cuda was an adviser to Novo Nordisk on pediatric obesity.

Obesity has been linked to many serious health conditions including diabetes, heart disease and cancer.

In prior years, a much smaller number of adolescents were prescribed Novo’s Saxenda, which was approved for adult weight loss in 2014 and for adolescents in 2020. Saxenda works in a similar way to curb appetite as Wegovy, but results in less weight loss on average. Both belong to a class of therapies known as GLP-1 agonists.

There were 378 adolescents prescribed Saxenda in the first 10 months of 2023, the Komodo data show. That was down from 567 patients who started to use the medication in 2022. From 2018 to 2021, 266 adolescents received new Saxenda prescriptions.

 

A FAMILY’S DECISION

Billy Small Jr. of Oakland, California, said he and his family were initially reluctant to put their 15-year-old son on Wegovy. They worried about side effects such as nausea, vomiting and other gastrointestinal problems, as well as potential unknown risks from long-term use.

Novo’s clinical trial of Wegovy in adolescents lasted about 18 months.

Their son, Billy Small III, was 5-foot-9 (1.75 meters) and weighed 385 pounds (176 kilograms) at the time. Their pediatrician warned that he was at increased risk of developing type 2 diabetes and heart disease. He had already been diagnosed with asthma.

"We asked Billy how he felt about it. He just really wanted the weight to be gone," said his father.

Since starting on Wegovy in March 2023, Billy has lost about 90 pounds, or 23% of his total body weight. The drug was covered by the family’s state Medicaid plan.

Billy’s appetite diminished sharply, and he rarely experienced side effects. He started to join friends for movies and basketball games and began going to the gym with his father.

"The weight was hard on his confidence," Billy Small Jr. said of his son, now 16. "His quality of life is already 100 times better than what it was."

Both Novo and Eli Lilly are testing their weight-loss drugs in children as young as 6. Lilly's drug, tirzepatide, is only approved for adults in the U.S. under the brand name Mounjaro for type 2 diabetes and Zepbound for weight loss.

Lilly said it couldn’t comment on "future plans for tirzepatide in children or adolescents as clinical trials are still ongoing."

Novo said there are about 175 million children and adolescents with obesity worldwide, and for some, a reduced-calorie diet and increased exercise may not be enough.

 

GLOBAL EPIDEMIC

The U.S. is among a handful of countries trying new weight-loss drugs in youth. Any lessons learned could inform health officials elsewhere. Novo said the drug received similar approvals for youth last year in Germany, the UK, Denmark and the United Arab Emirates.

Without insurance coverage, Wegovy can cost as much as $1,300 per month in the U.S. Data so far show a majority of people who stop taking it regain much of the lost weight. It is not clear whether there are ways to avoid using it for a lifetime.

Komodo reviewed health insurance claims involving nearly 20 million children, or about 80% of the U.S. population aged 12 to 17. Among these patients, 2.25 million adolescents had an obesity diagnosis listed in their insurance claims during the nearly six-year period reviewed. The analysis was conducted using closed insurance claims through October 2023.

 

Some medical experts urge caution given a lack of evidence about how these medications may affect development.

The U.S. Preventive Services Task Force recommended intensive counseling, including behavioral therapy and nutritional education, rather than medication, for helping children who need to lose weight.

"We don't really know what these medications do in the context of the growing child," said Dr. Dan Cooper, distinguished professor of pediatrics at the University of California at Irvine.

(Reporting by Robin Respaut in Oakland and Chad Terhune in Los Angeles Editing by Michele Gershberg and Bill Berkrot)