European Commission OK’s Novartis’s tuberous sclerosis complex drug

European Commission has approved Novartis’s 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).

Bruno Strigini, CEO, Novartis Oncology said that with approval of Votubia in the EU, patients with TSC suffering from refractory partial-onset seizures now have a new therapeutic option to address a critical unmet need.

As Novaris noted, Votubia is the only approved non-surgical option indicated for treating non-cancerous brain and kidney tumors in certain patients with TSC, a rare genetic disorder affecting up to one million people worldwide. Votubia works by inhibiting the mammalian target of rapamycin (mTOR), a protein that regulates multiple cellular functions, explained the company.