Votubia® (everolimus) tablets* is the first medical treatment approved in the European Union (EU) for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention and who are not likely to require surgery. The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease-related symptoms, has not been demonstrated. Votubia is also offered in a dispersible formulation to better accommodate TSC patients with SEGAs, including children who are unable to swallow tablets.
Votubia is also the only EU-approved medicine to treat adult patients with kidney tumors known as renal angiomyolipomas associated with TSC who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or bilateral tumors) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume.
Votubia targets mTOR, a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism.
This information is based on the European Summary of Product Characteristics. The prescribing information in your country may vary; please consult your local prescribing information and/or contact your local Novartis representative. Everolimus is not approved for this indication in all countries.
*Known as Votubia (everolimus) tablets for this patient population in the EU and Switzerland. Approved in the US for this patient population under the trade name Afinitor (everolimus) tablets.