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- 01/31/2017

Novartis drug Votubia® receives EU approval to treat refractory partial-onset seizures in patients with TSC

Pharma Horizon
  • Votubia is the first adjunctive treatment approved in the EU specifically for partial-onset seizures in children and adults with tuberous sclerosis complex (TSC)
  • Approval addresses unmet need as up to 60% of patients with TSC suffering from seizures become unresponsive to available anti-epileptic therapies[1]
  • Decision marks the third TSC-related indication for Votubia in the EU, where it is also approved to treat SEGA and renal angiomyolipomas[2]

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 associated 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[2].

“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,” said Bruno Strigini, CEO, Novartis Oncology. “This is a welcome advance and an important milestone in our ongoing commitment to improving care for this patient community.”

The EU approval of Votubia was based on efficacy and safety data from a pivotal Phase III study (EXIST-3: EXamining everolimus In a Study of TSC), which found that when used as an adjunctive therapy, Votubia significantly reduced the frequency of refractory partial-onset seizures associated with TSC compared to placebo. Efficacy and safety of two trough exposure concentrations of Votubia, 3-7 ng/mL (low exposure) and 9-15 ng/mL (high exposure) were assessed.