Aptiom sNDA for Pediatric Indication Accepted for Review
The sNDA is aimed at expanding the indication for Aptiom to include its use as monotherapy or adjunctive therapy for treating partial-onset seizures (POS) in children aged 4 to 17 years. Aptiom is currently the only once-daily, immediate release antiepileptic drug (AED) that is FDA-approved for use as monotherapy or adjunctive therapy for adult patients with POS.
The sNDA submission includes data from five controlled clinical trials in adults with POS and three clinical studies demonstrating safety and tolerability in pediatric patients. Pharmacokinetic data supporting the proposed dosing regimen is also included.
“We look forward to working closely with the FDA as we seek to bring Aptiom to young people with epilepsy who experience partial-onset seizures,” said Dr. Antony Loebel, EVP and CMO at Sunovion.
The mechanism by which eslicarbazepine exerts its anticonvulsant activity is not known but is thought to include inhibition of voltage-gated sodium channels.
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