Eisai Submits Supplemental New Drug Application (sNDA) to FDA for FYCOMPA (perampanel) Pediatric Indications
Eisai Inc. announced Friday (3/30/18) that it has submitted a supplemental New Drug Application (sNDA) for priority review to the U.S. Food and Drug Administration (FDA) for its antiepileptic drug Fycompa (perampanel) CIII as monotherapy and adjunctive use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in pediatric patients (ages 2 to less than 12 years). The submission also proposes a pediatric indication for monotherapy and adjunctive use for primary generalized tonic-clonic seizures (PGTC) in children (ages 2 to less than 12 years) with epilepsy.
An estimated 470,000 children in the U.S. are living with epilepsy today, and approximately 30% remain uncontrolled.
Fycompa is currently approved as therapy (including monotherapy use) for POS with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older and as adjunctive therapy for PGTC seizures in patients with epilepsy 12 years of age and older. To date, more than 100,000 patients have been treated with Fycompa worldwide across all indications.
Eisai is seeking approval for pediatric use based on a 2018 Draft Guidance noting the FDA's current thinking regarding clinical development programs that can support extrapolation of the effectiveness of drugs approved for the treatment of POS in adults to pediatric patients 4 years of age and older. This determination was based on the similarity of POS in adults and in pediatric patients four years of age and older, and on an analysis of multiple antiepileptic drugs, conducted by the FDA, that demonstrated a similar exposure-response relationship in pediatric and adult patients with POS.
In support of the extrapolation approach, the sNDA includes interim data from an ongoing global open-label, multicenter study (Study 311) with an extension phase that evaluated the safety, tolerability and exposure-efficacy relationship of perampanel oral suspension when administered as an adjunctive therapy in children, ages 4 through 11, with inadequately controlled POS or PGTC seizures.
The sNDA also includes data from an open-label pilot study (Study 232) with an extension phase to evaluate the pharmacokinetics, and to generate preliminary data on safety, tolerability, and efficacy of FYCOMPA oral suspension when given as an adjunctive therapy in pediatric subjects from 2 to less than 12 years of age with epilepsy.
Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group said, "Patients are better able to perform these activities to the best of their abilities when their cognition has not been meaningfully impaired by treatment. In a recent double-blind study of pediatric patients aged 12 to less than 18, Fycompa was shown to have no significant or clinically meaningful difference on cognition relative to placebo in patients with partial-onset seizures. While we never recommend missing a dose, life gets busy and it's easy to forget and accidentally miss a dose of your medication. FYCOMPA offers once daily dosing and has a 105-hour half-life, which means that available levels of the drug in the body reduce slowly over time."