Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Novartis’s Votubia (everolimus) dispersible tablets as an adjunctive treatment of patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC).
Tuberous sclerosis complex is a rare genetic disorder affecting up to one million people worldwide. Approximately 85% of individuals with TSC are affected by epilepsy, and uncontrolled seizures associated with TSC can be debilitating for patients.
If approved by the European Commission (EC), Votubia would address an unmet need as currently there are no pharmacologic treatments approved specifically for the treatment of refractory seizures associated with TSC, Novartis noted in its press release.
“As refractory seizures are among the most debilitating manifestations of TSC, a new therapy that provides seizure control would be a meaningful advance for these patients in the EU,” said Bruno Strigini, CEO, Novartis Oncology.
The EC typically adheres to the recommendation of the CHMP and usually delivers its final decision in two months or earlier. The decision will be applicable to all 28 European Union (EU) member states plus Iceland and Norway. In Europe, everolimus has orphan drug designation for TSC.