Novartis AG (NVS) said it obtained approval from the European Commission, or EC, for Votubia (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex, or TSC, who are at risk of complications but who do not require immediate surgery.
According to the company, the 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. 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.
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