The Food and Drug Administration’s approval of Wegovy, Novo Nordisk’s latest obesity drug, for adolescents aged 12 years and older opens up a highly-anticipated tool in the fight against childhood obesity, but some doctors warn the sought-after medication isn’t a magic bullet.
The move comes after the FDA approved Wegovy (semaglutide) for weight management in adults in 2021.
Though the FDA approved Novo Nordisk’s earlier obesity drug, Saxenda, for weight loss in adolescents in December 2020, there’s greater interest in Wegovy since it’s injected weekly instead of daily and it has been shown to have greater effects on weight loss. The drug, which mimics the effects of hormones that can help people feel full after eating, led to an average 16% reduction in body-mass index in teens in a 68-week trial.
The FDA’s decision comes as rates of childhood obesity surge, with about 20% of children and adolescents in the U.S. having the condition. Many doctors have awaited the approval of a new drug in a field that’s long lacked highly effective and safe medications.
But some are cautioning against a rush to use it.
“I’m concerned that doctors are going to rush to judgment and employ a medication that is very expensive and has its own side effects without giving proper consideration of what the actual cause of the problem is,” said Robert Lustig, professor emeritus of pediatrics at the University of California, San Francisco. Wegovy costs more than $1,300 per month and can cause nausea, vomiting, and rare cases of pancreatitis.
Lustig said each teen’s obesity is caused by different genetic, environmental, and behavioral factors and requires tailored treatment. He worries that widespread use of Wegovy could lead physicians to overlook the root causes of an individual’s condition.
“Treating the downstream symptoms of the problem is only putting a Band-Aid on the problem, it’s not fixing the problem,” Lustig said. “I’m worried that Wegovy is a Band-Aid.”
Since Wegovy, Saxenda, and other drugs are meant to be taken over the long term to maintain weight loss — potentially the rest of an individual’s life — teenagers would be on the medication for an especially long time, and there isn’t yet information on the effects of the drug over that time span, Lustig added.
Fatima Cody Stanford, an obesity medicine physician-scientist at Massachusetts General Hospital in Boston, is more enthusiastic about the medication. “I’m extremely excited because we do have more limited options available for the use in pediatric patients,” she said. “The earlier the intervention, the better in terms of shaping their metabolic health.”
There haven’t been significant safety concerns in similar drugs that have been on the market for longer, such as Saxenda, said Stanford, who consults for Novo Nordisk.
But ensuring that the drugs are used appropriately in those who need them will be critical, said Stanford. As Wegovy and similar medications have been rolled out, some adults who don’t have obesity have sought them out for their weight-loss effects.
“There is a risk for these medications being used inappropriately like we’ve seen in the adult population, particularly in patients that may have a history of disordered eating,” Stanford said. “I would hope that physicians and other advanced practice providers that have the ability to prescribe will be thoughtful about the implications behind the use of these medications.”
In the meantime, doctors and patients will likely face challenges getting the drug. There have been shortages of Wegovy since March due to manufacturing issues. While the company this week reported all doses are now available to retail pharmacies nationwide, it’s still ramping up production capacity.
Novo Nordisk expects a second contract manufacturer to come online in the first half of 2023 and a second site at the current manufacturer to start later in the year, it said in an emailed statement.
Amid the potentially tight supply, the rollout of the drug threatens to widen health disparities. Recent research has found that living in less advantaged areas is linked to a greater risk of developing obesity during childhood and adolescence. Communities that may need the drug the most may be least able to afford the medication, which isn’t covered by many insurers, said Kavitha Selvaraj, medical director of the wellness and weight management program at Lurie Children’s Hospital of Chicago.
“We will continue to work within the current health care system to obtain broader coverage and greater access,” Novo Nordisk said in its statement.
Equitable distribution is especially important when treating adolescents because untreated obesity early in life can lead to health problems such as diabetes and heart disease later on, Selvaraj said. “The importance of acting early in childhood and adolescence really can’t be overstated.”