The Food and Drug Administration recently expanded the coverage of an effective obesity drug known as Wegovy to children up to the age of 12. In clinical trials, children who took Wegovy lost significantly more weight than those who took a placebo. Expanding labels is the latest success story for this new generation of obesity treatments, but the drugs themselves continue to be in short supply, uninsured and expensive.
FDA approved Wegoby Intended for adults with a BMI greater than 30 (definition of obesity) or a BMI greater than 27 and with at least one potentially weight-related condition, such as high blood pressure, in June 2021. It was the first new obesity drug approved in seven years. However, Wegovy’s active ingredient, called semaglutide, was previously approved by the FDA in 2017 as a low-dose formulation for his type 2 diabetes and marketed under the brand name Ozempic. Both Wegovy and Ozempic are manufactured by Danish pharmaceutical company Novo Nordisk.
The large randomized controlled clinical trial that led to Wegovy’s initial approval showed that the once-weekly injectable drug helped people over the age of 68 lose an average of 12.4% of their initial body weight .About 15% weight loss over a week or in total compared to those who received placebo. Wegovy also seems to work just as well for her teens.
According to the results of the company’s STEP TEENS trial, It was published Last month’s New England Journal of Medicine found that teenagers who took the drug lost an average of 14.7% of their initial body weight over the course of the year, while those who took a placebo 2.7% increase on average.The treatment group also saw an average of 16.1% decrease in BMI compared to a 0.6% increase in the placebo group. Wegovy Safety Profile Teenagers are similar. The most common adverse events reported in these trials included nausea, vomiting, and diarrhea. These often appeared early in treatment as people gradually increased their dosage and faded over time. similar (about 5%).
Obesity rates continue to increase over time in the United States and many parts of the world. teens and young childrenThese tendencies are acceleration in the meantime covid-19 pandemic.and though it remains much discussion Rather than 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.
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“Teenage obesity rates in the United States continue to rise, impacting teenagers and their families. Co-Director of the University of Minnesota Pediatric Obesity Medical Center and co-author of the STEP-TEENS study As Aaron S. Kelly, statement It was released by Novo Nordisk last week following the FDA’s decision. “This FDA approval provides an additional tool to address this serious, chronic, and progressive disease.”
Until now, medications have been moderate at best for weight loss or have been associated with dangerous side effects, such as stimulants that can lead to unhealthy dependence. A balanced diet and exercise are healthy for many reasons, but generally unattainable and Significant weight loss can be maintained simply by making lifestyle changes. many, but not necessarily allExperts agree that semaglutide is the first in a class of drugs known as incretins that, along with many other possible health benefits, may lead to sustained and safe weight loss. doing.
At the same time, Wegovy short supply ever since its debut, Unexpected demand and production issues last year led to the temporary closure of one of Novo Nordisk’s main manufacturing facilities.These shortages may have led to an increase in off-label prescriptions for Ozempic. Even now of limited supply. aat least some patients complained As a result, he was denied Ozempic because of preexisting diabetes.
Novo Nordisk believes these supply issues Clean up early next year. But even then, Wegovy and similar drugs, which are expected to be approved soon, remain out of reach for many. because of them large amount price tagCurrently, obesity drugs are generally not covered by Medicare, and many private insurance companies are reluctant to cover Wegovy. So far. Without insurance, Wegovy could cost upwards of $1,500 a month, and many patients would likely have to keep taking it to maintain their weight loss.
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