EU approval for Votubia to treat refractory partial-onset seizures in patients with TSC

31 January 2017

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 associated with tuberous sclerosis complex (TSC).

Swiss pharma giant’s Novartis’ (NOVN: VX) Votubia is now the first approved pharmacologic therapy in all 28 member states of the European Union, plus Iceland and Norway, specifically for the treatment of refractory partial-onset seizures associated with TSC, the company stated.

This marks the third TSC-related indication for Votubia in the EU, where it is also approved to treat subependymal giant cell astrocytoma and renal angiomyolipomas. Also marketed as Afinitor in the USA, the drug generated sales of $1.52 billion in 2016.

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