EMA approves Novartis’ Votubia

Novartis announced that EMA has approved Votubia (everolimus) dispersible tablets as an adjunctive treatment for patients two years of age and older with refractory partial-onset seizures, with or without secondary generalization, associated with TSC (tuberous sclerosis complex). The approval makes Votubia the first drug for the treatment of such condition approved in Europe. The decision by EMA follows the results of the EXIST-3 Phase III study. TSC is a rare genetic disorder affecting approximately one million people worldwide. About 85% of the affected individuals suffer from epilepsy as well. (Source Novartis press release)