Sunovion Pharmaceuticals announced that Health Canada approved the Supplemental New Drug Submission (SNDS) to expand the indication for its antiepileptic drug (AED) Aptiom (eslicarbazepine acetate) to include use as an adjunctive therapy for the treatment of partial-onset seizures (POS) 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 POS in adults living with epilepsy. Aptiom is a once-daily, immediate release AED that can be taken whole or crushed, with or without food.
“The unpredictability of partial-onset seizures is one of the most challenging aspects of this condition—for children and their families,” said Anne Lortie, M.D., FRCPC, associate professor of Neurology, CHU Sainte Justine, Montreal, Quebec. “This expanded indication for Aptiom in Canada helps to bring an important treatment option to children and adolescents for whom previous treatments have not been able to control their partial-onset seizures.”
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 pediatric patients and a population pharmacokinetic study, which was used to support the recommended dosing regimen in the pediatric population. The safety and efficacy in pediatric patients six years of age and below have not been established.
“We are proud of this milestone approval by Health Canada for the use of APTIOM, as an adjunctive therapy, for children and adolescents,” said David Frawley, executive vice president and chief commercial officer at Sunovion. “This approval strengthens our commitment to advancing therapies for people living with neurological conditions like epilepsy.”
(Source: Sunovion Pharmaceuticals Inc.)