Novartis' Votubia (everolimus) approved in Europe
This article was originally published in Scrip
Executive Summary
The European Commission (EC) has approved Novartis' oral everolimus tablets for the treatment of patients aged three years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC), who require therapeutic intervention but are not amenable to surgery. Prior to this, brain surgery was the only treatment option for children and adults in the EU with the rare genetic disease. It will be marketed as Votubia in SEGA with TSC indication.