From Financial Post · GlobeNewswire · · 2m
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.
In brief
VIVUS secures European approval to extend QSIVA for adolescents with obesity, offering evidence-based treatment options. VIVUS received positive EU approval for QSIVA to treat adolescents aged 12 and older with obesity, providing a therapeutic option alongside lifestyle changes. Originally reported by Financial Post.
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.
What matters most
VIVUS received positive EU approval for QSIVA to treat adolescents aged 12 and older with obesity, providing a therapeutic option alongside lifestyle changes.
