The Food and Drug Administration recently expanded the eligibility of an effective obesity drug known as Wegovy to children as young as 12 years old. In a clinical trial, children who took Wegovy lost significantly more weight than those who took a placebo. The label expansion is the latest success in this new generation of obesity treatments, though the drugs themselves continue to be scarce 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 possible weight-related condition, such as high blood pressure. It was the first new obesity treatment approved in seven years. However, the active ingredient in Wegovy, called semaglutide, was previously approved in a low-dose formulation by the FDA for type 2 diabetes in 2017, sold under the brand name Ozempic. Wegovy and Ozempic are made by Danish pharmaceutical company Novo Nordisk.
In the major randomized, controlled clinical trials that led to Wegovy’s initial approval, the once-weekly injectable drug was shown to help people lose an average of 12.4% of their initial body weight over a period of time. from 68 toweek period compared to people who took a placebo, a weight loss of about 15%. And Wegovy seems 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, teenagers who took the drug lost an average of 14.7% of their initial body weight in a year, while those on placebo gained 2.7% on average. The treatment group also saw an average of 16.1% loss in BMI, compared to a 0.6% increase in the placebo group. Wegovy’s safety profile Seems to be similar in adolescents. The most common adverse events reported in these trials include nausea, vomiting and diarrhea, which often started early in treatment as people gradually increased their dose and decreased over time. The dropout rate, or people deciding to stop taking treatment, was low and similar in both groups (around 5%).
Obesity rates have continued to rise in the United States and many parts of the world over time, including among teenagers and young children. These trends do not seem to have accelerated during the covid-19 pandemic. And although there remains a lot of debate In addition to the exact health effects of obesity, childhood obesity is thought to increase the risk of serious health problems later in life, such as type 2 diabetes.
G/O Media may receive a commission
Keep those toes toasty
You lose heat through your feet and head—so warm up with these rechargeable heated socks with an impressive battery life.
“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 published last week by Novo Nordisk following the FDA decision. “This FDA approval provides an additional tool to combat this serious, chronic, and progressive disease.”
Drugs so far have been modestly effective at best in helping people lose weight, or have had dangerous side effects, such as stimulants that can cause unhealthy addiction. And while a balanced diet and exercise are healthy for many reasons, people usually fail to achieve it. maintain significant weight loss through lifestyle changes alone. numerous, but not necessarily allExperts agree that semaglutide represents the first in a class of drugs known as incretins that can lead to long-lasting and safe weight loss, along with many other possible health benefits.
At the same time, Wegovy has been in shortage because his beginnings, due to unexpected demand and production issues last year that caused the temporary closure of one of Novo Nordisk’s major manufacturing facilities. These shortages likely led to an increase in off-label prescriptions of Ozempic, which is now too in. in limited supply. Aat least some patients have complained that they were denied Ozempic for their existing diabetes as a result.
Novo Nordisk claimed that these supply issues be clarified by early next year. But even if that happens, Wegovy and similar drugs that are expected to be approved soon will remain out of reach for many people. due to their heavy price tag. Obesity drugs in general are currently not eligible for Medicare coverage, and many private insurers have been reluctant to cover Wegovy. so far. Without insurance, Wegovy can cost up to $1,500 per month, and it’s likely that many patients will need to continue taking it to maintain weight loss.
0 Comments