VIVUS LLC announced the US Food and Drug Administration's approval of QSYMIA (phentermine and topiramate extended-release capsules) for the treatment of obesity in adolescents ages 12 to 17 years.
Today, VIVUS LLC announced the US Food and Drug Administration has approved QSYMIA (phentermine and topiramate extended-release capsules) for the treatment of obesity in adolescents ages 12 to 17 years with an initial body mass index (BMI) in the 95th percentile or greater standardized for age and sex, according to a company press release.1
The decision is backed by positive results from a recent phase 3 trial, which demonstrated that of patients who received the top dose, over 44% of patients lost 15% of their body weight and more than 30% of patients lost at least 20% of their body weight.1
"Up to 90% of adolescents with obesity are likely to have obesity as adults, putting them at increased risk for developing weight-related complications,” said Aaron Kelly, PhD, professor of pediatrics and co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota.
He added, “Consequently, it is important to address weight care and offer support early on. New options to treat adolescents who live with obesity can bring much-needed hope to families and help address this growing epidemic, and the approval of QSYMIA in this patient population gives health care providers a new tool for developing personalized, complete care plans to help adolescents lose weight and keep it off."
1. FDA approves qsymia for the treatment of obesity in adolescents ages 12-17. GlobeNewswire News Room. July 20, 2022. Accessed July 20, 2022. https://www.globenewswire.com/news-release/2022/07/20/2482773/0/en/FDA-Approves-QSYMIA-for-the-Treatment-of-Obesity-in-Adolescents-Ages-12-17.html