Novartis’ Votubia approved in Europe for tuberous sclerosis complex

Novartis has announced that its drug Votubia has been approved by the European Commission for the treatment of patients with tuberous sclerosis complex (TSC).

The dispersible tablet therapy has been ratified as an adjunctive treatment for patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with TSC.

Votubia is now the first approved pharmacologic therapy in Europe specifically for the treatment of this condition, and addresses an unmet need, as 60 percent of TSC patients suffering from seizures become unresponsive to current antiepileptic therapies.

Data from the phase III study EXIST-3 showed that when used as an adjunctive therapy, Votubia significantly reduced the frequency of refractory partial-onset seizures associated with TSC compared to placebo.

Bruno Strigini, chief executive officer of Novartis Oncology, said: "This is a welcome advance and an important milestone in our ongoing commitment to improving care for this patient community."

The drug is also approved for the treatment of subependymal giant cell astrocytoma and renal angiomyolipomas.

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