Posted by Michael Wonder on 19 Sep 2018
Sunovion announces Health Canada approval of Aptiom (eslicarbazepine acetate) as adjunctive therapy for the treatment of partial-onset seizures in adolescents and children above six years of age
19 September 2018 - Sunovion Pharmaceuticals today announced that Health Canada approved the supplemental new drug submission to expand the indication for its anti-epileptic drug Aptiom (eslicarbazepine acetate) to include use as an adjunctive therapy for the treatment of partial-onset seizures in adolescents and children above six years of age who are not satisfactorily controlled with conventional therapy.
Aptiom is also approved in Canada as monotherapy and adjunctive therapy for the treatment of partial-onset seizures in adults living with epilepsy.
The safety and efficacy of Aptiom as an adjunctive therapy in the treatment of POS in adolescents and children above six years of age have been established using data from clinical studies in paediatric patients and a population pharmacokinetic study, which was used to support the recommended dosing regimen in the paediatric population. The safety and efficacy in paediatric patients six years of age and below have not been established.
