FDA Approves Expanded Seizure Indication for Aptiom
The expanded approval for Aptiom was based on the FDA guidance that allows data extrapolation to support pediatric use.
Sunovion announced that the Food and Drug Administration (FDA) has approved an expanded indication for Aptiom (eslicarbazepine acetate) tablets to include the treatment of partial-onset seizures (POS) in children and adolescents aged 4–17 years. Aptiom is already approved to treat POS in adults.
The expanded approval for Aptiom was based on the FDA guidance that allows data extrapolation to support pediatric use. The efficacy and safety of Aptiom as monotherapy and adjunct therapy for adults with POS was previously established in 5 multicenter, randomized, controlled studies. This data also supported the safety and tolerability of Aptiom for the treatment of pediatric patients with POS.
The dosing regimen for children and adolescents was supported by the pharmacokinetic analyses of adult and pediatric data.
Aptiom, a dibenzazepine antiepileptic, is thought to exert its action through inhibition of voltage-gated sodium channels. Aptiom is available as 200mg, 400mg, 600mg, and 800mg strength tablets.
Sunovion's Aptiom® (eslicarbazepine acetate) Receives FDA approval for expanded indication to treat partial-onset seizures in children and adolescents 4 years of age and older [press release]. Marlborough, MA: Sunovion Pharmaceuticals; September 14, 2017.