Posted by Michael Wonder on 17 Dec 2016
Novartis drug Votubia recommended by CHMP for EU approval to treat refractory partial-onset seizures in patients with TSC
16 December 2016 - CHMP positive opinion based on pivotal study showing adjunctive treatment with everolimus achieved clinically significant seizure reduction in patients with TSC.
Novartis today announced that the CHMP) of the EMA adopted a positive opinion for Votubia (everolimus) dispersible tablets as an adjunctive treatment of patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex (TSC).
If approved by the European Commission, Votubia would address an unmet need as currently there are no pharmacologic treatments approved specifically for the treatment of refractory seizures associated with TSC.
