January 31, 2017
Novartis has announced that the European Commission has approved Votubia® (everolimus) dispersible tablets as an adjunctive treatment for patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalization, are connected with tuberous sclerosis complex (TSC). Votubia is now the first approved pharmacologic therapy in all 28 member states of the European Union (EU), plus Iceland and Norway, specifically for the treatment of refractory partial-onset seizures associated with TSC.
Bruno Strigini, CEO, Novartis Oncology, said: “With this latest approval of Votubia in the EU, patients with TSC suffering from refractory partial-onset seizures – one of the most debilitating manifestations of TSC – now have a new therapeutic option to address a critical unmet need. This is a welcome advance and an important milestone in our ongoing commitment to improving care for this patient community.”
This EU approval of Votubia was based on safety and efficacy data from a pivotal Phase III study, which identified that when used as an adjunctive therapy, Votubia reduced the frequency of refractory partial-onset seizures associated with TSC compared to placebo significantly.