EU approves Votubia (Novartis)for Renal Angiomyolipoma

Novartis received approval from the European Commission (EC) for Votubia (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (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. This marks the first approval of a medical treatment in this patient population in Europe.

This approval is based on data from the Phase III EXIST-2 (EXamining everolimus In a Study of TSC) trial, which found that 42% of patients taking everolimus experienced an angiomyolipoma response versus 0% of patients in the placebo arm (p<0.0001). the evidence is based on analysis of the change in the sum of the angiomyolipoma volume. median time to angiomyolipoma progression was 11.4 months in the placebo arm and was not reached in the everolimus arm p><0.0001).>