- 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.
Important Safety Information
QSIVA (phentermine/topiramate MR) is contraindicated in pregnancy and in women of childbearing potential not using highly effective contraception, as topiramate can cause major congenital malformations. Do not use QSIVA in patients with glaucoma, hyperthyroidism, or MAOI use. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking topiramate, an ingredient in QSIVA. QSIVA may cause increased heart rate, mood changes, and cognitive disturbances; caution is advised when driving. Common adverse reactions include paraesthesia, dizziness, altered taste, insomnia, constipation, and dry mouth.
Forward-Looking Statements
Important Information and Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and/or covered by the "Bespeaks Caution" doctrine applied by the courts under the antifraud provisions of the federal securities laws, and other applicable provisions of the federal securities laws. Such forward-looking statements are based on current expectations, management's beliefs, and certain assumptions made by the Company's management. These statements may be identified by the use of forward-looking words such as "will," "shall," "may," "believe," "expect," "forecast," "intend," "anticipate," "predict," "should," "plan," "likely," "opportunity," "estimated," and "potential," and/or the negative use of these words or other similar words. All forward-looking statements included in this document are based on the Company's current expectations, and the Company assumes no obligation to update any such forward-looking statements except to the extent otherwise required by law.
Forward-looking information about QSIVA, including statements regarding the expected extension of its indication to adolescents aged 12 years and older, the timing and outcome of national decisions in the 17 countries in the procedure, its clinical efficacy and safety profile in adolescents, and its role in long-term obesity management, involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release.
Risks related to QSIVA include whether, and when, the national medicines agencies in each country will issue decisions extending the indication to adolescents; the final wording of the adolescent indication, warnings and other labeling agreed in each country; conditions of use in adolescents, including the requirements of the topiramate pregnancy prevention program for adolescents of childbearing potential; whether, and when, pricing and reimbursement will be obtained for adolescent use in each country; acceptance of QSIVA by pediatric and other prescribers, patients and families; new safety findings or adverse events in the adolescent population, including from post-authorization commitments; competitive developments in the weight management market including injectable medications and other treatments approved for adolescents, and whether QSIVA will continue to be commercially successful in approved markets.
General risks include the ability to successfully manage commercial programs across multiple international markets; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of QSIVA; supply chain challenges; and competitive developments in the obesity and weight management therapeutic area.
The above factors, risks, and uncertainties are difficult to predict, contain uncertainties that may materially affect actual results, and may be beyond the Company's control. New factors, risks, and uncertainties emerge from time to time, and it is not possible for management to predict all such factors, risks, and uncertainties. Although the Company believes that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore any of these statements may prove to be inaccurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by the Company or any other person that the Company's objectives and plans will be achieved. These forward-looking statements speak only as of the date such statements were made or any earlier date indicated, and the Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in underlying assumptions, or otherwise, unless otherwise required by law. This announcement is made in accordance with applicable securities regulations including the EU Market Abuse Regulation. This press release is intended for the European market only.
Contacts
VIVUS BV
T: +31 20 262 0959
Media - FINN Partners
Julian Tyndale-Biscoe
julian.tyndale-biscoe@finnpartners.com
T: +44 20 7046 8280
* 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.
