# VIVUS Gets EU Approval for QSIVA to Treat Adolescent Obesity

> VIVUS secures European approval to extend QSIVA for adolescents with obesity, offering evidence-based treatment options.
- Title: VIVUS Gets EU Approval for QSIVA to Treat Adolescent Obesity
- Summary: VIVUS secures European approval to extend QSIVA for adolescents with obesity, offering evidence-based treatment options. VIVUS received positive EU approval…
- Keywords: vivus, qsiva, obesity, adolescents, european, phentermine, topiramate, weight management, pediatric care, european medicines agency, money, business
- Source: Financial Post — https://financialpost.com/globe-newswire/vivus-announces-positive-outcome-of-european-procedure-to-extend-qsiva-phentermine-topiramate-mr-to-adolescents-with-obesity
- Author: GlobeNewswire
- Published: 2026-10-19T13:04:11+00:00
- Read time: 2 min
- Topics: vivus, qsiva, obesity, adolescents, european, phentermine, topiramate, weight management, pediatric care, european medicines agency, money, business
## VIVUS Announces EU Approval
VIVUS BV, a subsidiary of VIVUS LLC, announced positive conclusion of European variation procedure to extend QSIVA for adolescents aged 12 years and older with obesity.
## 17 Countries Expected to Approve
National medicines agencies of 17 countries will issue national decisions within 30 days after positive outcome of variation procedure.
## QSIVA Already Approved for Adults
QSIVA is approved in 17 European countries for weight management in adults: Croatia, Czechia, Denmark, Finland, Greece, Hungary, Iceland, Ireland, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
## CEO Statement on Adolescent Obesity
John Amos, CEO of VIVUS LLC, stated adolescent obesity is a pressing public health challenge requiring evidence-based treatments when lifestyle changes alone aren't sufficient.
## Clinical Trial Results
A 2022 study showed QSIVA's safety and efficacy over 56 weeks in 223 adolescents with obesity.
## Medical Officer on Early Treatment
Santosh T. Varghese, MD, noted treating obesity early breaks cycles causing lifelong health issues and provides tools for adolescents.
## Global Obesity Impact
Obesity increases risks of heart disease, autoimmune diseases, and type 1 diabetes across Europe.
## QSIVA Brand Names
VIVUS markets QSIVA under brand name QSYMIA in the US, Greece, and MENA region, and QSIVA in Europe.
## US Approval Timeline
QSYMIA has been available in the US since 2012 and was extended to adolescents on June 27, 2.022.
## MENA Launch
VIVUS launched QSYMIA in the UAE for adults and adolescents aged 12 and older in March 2025, entering MENA region.
## Adolescent Indication Extension
QSIVA will now be extended to adolescents in 17 European countries following national approvals.
## Key Safety Information
QSIVA is contraindicated in pregnancy, women of childbearing potential without effective contraception, and patients with glaucoma or hyperthyroidism.
## Key takeaway

VIVUS received positive EU approval for QSIVA to treat adolescents aged 12 and older with obesity, providing a therapeutic option alongside lifestyle changes.