— Landmark European approval will grant young patients and families an evidence-based therapy alongside lifestyle interventions
AMSTERDAM, Oct. 19, 2026 (GLOBE NEWSWIRE) -- VIVUS BV, a subsidiary of VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs and life-limiting diseases, today announced the positive conclusion of the European variation procedure to extend the indication of QSIVA® (phentermine/topiramate MR) to adolescents aged 12 years and older with obesity. The national medicines agencies of the 17 countries in the procedure will now issue national decisions, expected in as little as 30 days. QSIVA® is already approved in these countries for weight management in adults: Croatia, Czechia, Denmark, Finland, Greece*, Hungary, Iceland, Ireland, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
"Adolescent obesity represents one of the most pressing public health challenges in Europe today," said John Amos, Chief Executive Officer at VIVUS LLC. "Securing broader access for QSIVA® allows us to bridge a significant gap in pediatric care, offering clinicians and families an evidence-based treatment option when lifestyle changes alone aren't enough."
The positive outcome of the variation procedure was based on results from a 2022 study, a double-blind, placebo-controlled, clinical trial that evaluated the safety and efficacy of phentermine/topiramate MR over a 56-week period in 223 adolescents with obesity.
"Treating obesity early in life is critical to breaking a cycle that can cause severe, lifelong health issues," said Santosh T. Varghese, MD, President at VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. "With broader European access to QSIVA®, healthcare providers will have a therapeutic tool to help adolescents manage weight alongside diet and exercise before long-term complications set in."
Globally, obesity and overweight pose significant public health challenges, impacting millions of people across Europe. These conditions increase the risk of various health problems, such as heart disease and autoimmune diseases, such as multiple sclerosis, Crohn’s disease, arthritis, and type 1 diabetes.
VIVUS markets its phentermine/topiramate extended-release therapy under the brand name QSYMIA® in the United States, Greece, and the Middle East and North Africa (MENA) region, and under the brand name QSIVA®, the European brand name for QSYMIA®, in approved countries across Europe. QSYMIA has been available in the United States since 2012, and its indication was extended to adolescents aged 12 years and older on June 27, 2022. In March 2025, VIVUS launched QSYMIA® in the United Arab Emirates for adults and pediatric patients aged 12 and older, marking the company’s entry into the MENA region.
QSIVA® is already approved for adults in 17 European countries, and will now be extended to adolescents in these same countries following national approvals. For more information about QSIVA, please visit https://qsiva.eu/.
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 QSIVA®
QSIVA® (phentermine/topiramate MR) (the European brand name for QSYMIA®) is approved in Croatia, Czechia, Denmark, Finland, Greece, Hungary, Iceland, Ireland, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden. QSIVA® 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. The effect of QSIVA® on reducing cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSIVA® in combination with other products intended for weight loss, including prescription and over-the-counter drugs and herbal preparations, have not been established. For more information on QSIVA®, please visit www.QSIVA.eu. The website is accessible for healthcare professionals only through registration.
