FDA Approves QSYMIA® for the Treatment of Obesity in Adolescents Ages 12-17
VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved QSYMIA (phentermine and topiramate extended-release capsules) CIV for use in the treatment of obesity in adolescents (12-17 years old) with an initial body-mass index (BMI) in the 95th percentile or greater standardized for age and sex. According to the CDC, approximately 22% of children aged 12-19 years in the United States — about 14 million individuals — have obesity.
The results of the QSYMIA Phase 3 trial in adolescent patients taking the top-dose demonstrated that more than 44% of patients lost at least 15% of their body weight and more than 30% of patients lost at least 20% of their body weight.
"Up to 90 percent of adolescents with obesity are likely to have obesity as adults, putting them at increased risk for developing weight-related complications,” said Dr. Aaron Kelly, Professor of Pediatrics and co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota. “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 healthcare providers a new tool for developing personalized, complete care plans to help adolescents lose weight and keep it off."
Adolescence is a critical period for the development of obesity. Obesity arises from a complex interaction among numerous factors, including a strong biological component. The increased prevalence of adolescent obesity in the United States and its associated short- and long-term complications underscore the need for safe and effective treatment. Chronic obesity-related health conditions such as type 2 diabetes, insulin resistance, hypertension, dyslipidemia, obstructive sleep apnea and fatty liver disease, were previously only seen in adults but are now being diagnosed with increasing frequency in adolescents. Obesity also diminishes adolescents’ quality of life, and excess adiposity often carries into adulthood.
“As a company committed to innovating new solutions for the obesity crisis, the FDA approval of QSYMIA for the treatment of obesity in adolescents is an important milestone for our dedicated team,” said Dr. Santosh T. Varghese, Senior Vice President, Chief Medical Officer of VIVUS LLC. “It also is an important advancement for the patients and physicians who face the daily personal and public health challenges that result from the rise in adolescent obesity. One of these challenges is the limited treatment options for adolescents with obesity, and we are gratified that our continued evaluation of QSYMIA in specific patient populations has resulted in a new FDA-approved therapy in this indication.”
“VIVUS is committed to ensuring that any patient or physician who desires an oral solid medication for therapeutic-induced weight loss will have access to QSYMIA, one of the most cost-effective branded pharmaceutical obesity therapies,” said John Amos, CEO of VIVUS LLC. “QSYMIA already is approved in eight countries, and we will continue to pursue additional approvals to increase patient access.”
About VIVUS
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit http://www.vivus.com.
About QSYMIA
QSYMIA is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol, and in pediatric patients aged 12 years and older with BMI in the 95th percentile or greater standardized for age and sex.
The effect of QSYMIA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSYMIA in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Published: Jul 20, 2022
