The Food and Drug Administration has recently expanded the eligibility of an effective obesity drug known as Wegovy to children as young as 12. In a clinical trial, children who took Wegovy lost far more weight than those who took a placebo. The label expansion is the latest success for this new generation of obesity treatments, though the drugs themselves continue to be in short supply and expensive without insurance coverage.
The FDA approved Wegovy in June 2021 for adults with a BMI over 30 (the definition of obesity) or with a BMI over 27 and at least one possibly weight-related condition, such as high blood pressure. It was the first new obesity treatment approved in seven years. However, the active ingredient of Wegovy, called semaglutide, had previously been approved in a lower dose formulation by the FDA for type 2 diabetes in 2017, sold under the brand name Ozempic. Both Wegovy and Ozempic are made by the Danish pharmaceutical Novo Nordisk.
In the major randomized and controlled clinical trials that led to Wegovy’s original approval, the once-weekly injectable drug was shown to help people lose an average of 12.4% of their initial body weight over a 68-week period compared to people who received placebo, or about a total 15% weight loss. And Wegovy appears to be just as effective in teens.
According to the results of the company’s STEP TEENS trial, published last month in the New England Journal of Medicine, teens who took the drug lost an average 14.7% of their initial body weight over a year’s time, while those on placebo gained 2.7% on average. The treatment group also saw an average 16.1% loss in BMI, compared to a 0.6% increase in the placebo group. The safety profile of Wegovy seems to be similar in teens. The most common adverse events reported in these trials include nausea, vomiting, and diarrhea, which often appeared early on in treatment as people gradually increased their dosage and waned over time. The rate of discontinuation, or people who decide to stop taking treatment, was low and similar across both groups (around 5%).
Obesity rates have continued to increase in the U.S. and many parts of the world over time, including among teens and young children. These trends only seem to have accelerated during the covid-19 pandemic. And though there remains much debate over the exact health effects of obesity, childhood obesity is thought to raise the risk of serious health problems later in life, such as type 2 diabetes.
“The prevalence of teen obesity in the U.S. continues to rise, affecting teens and their families. Now, more than ever, we need new options to support teens,” said Aaron S. Kelly, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota and one of the STEP-TEENS study authors, in a statement released last week by Novo Nordisk following the FDA’s decision. “This FDA approval offers an additional tool to address this serious, chronic, progressive disease.”
Up until now, medications have been modestly effective at best in helping people lose weight, or have come with dangerous side-effects, such as stimulants that can cause an unhealthy dependence. And while a balanced diet and exercise is healthy for many reasons, people generally do not achieve and maintain significant weight loss through lifestyle changes alone. Many, but not necessarily all, experts agree that semaglutide represents the first in a class of drugs, known as incretins, that can lead to sustained and safe weight loss, along with many other possible health benefits.
At the same time, Wegovy has been in short supply since its debut, due to unexpected demand and production issues last year that caused the temporary shutdown of one of Novo Nordisk’s key manufacturing facilities. These shortages have likely led to an increase in off-label prescriptions of Ozempic, which is now also in limited supply. At least some patients have complained that they’ve been denied Ozempic for their previously existing diabetes as a result.
Novo Nordisk has claimed that these supply issues will be cleared up by early next year. But even if that happens, Wegovy and similar drugs expected to be approved soon will remain out of reach for many people, due to their hefty price tag. Obesity drugs in general aren’t eligible to be covered by Medicare currently, and many private insurers have been reluctant to cover Wegovy so far. Without insurance, Wegovy can cost upwards of $1,500 a month, and it’s likely that many patients will need to keep taking it in order to maintain their weight loss.