VOTUBIA (everolimus), mTOR inhibitor

Substantial improvement when a subependymal giant cell astrocytoma associated with tuberous sclerosis complex is not immediately eligible for surgical resection

• VOTUBIA, available as a tablet and dispersible tablet, now has Marketing Authorisation in children under age 3 years in subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex, in patients who require therapeutic intervention but are not eligible for SEGA surgical resection.

• This treatment is superior to placebo for reducing the SEGA volume, but has not shown any improvement in the symptoms related to the disease. 

• Its therapeutic benefit is substantial only to prepare patients for surgery in certain advanced SEGA cases and for patients for whom its severity justifies a surgical procedure, but who are not amenadable to surgery.