• Eisai Submits Supplemental New Drug Application (sNDA) to FDA for FYCOMPA Pediatric Indications

    • March 31, 2018
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    First step to making FYCOMPA available for children, underscoring Eisai’s commitment to epilepsy care for patients of all ages

    Eisai Inc. announced today 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. The sNDA is for both the FYCOMPA tablet and oral suspension formulations.

    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. 

    An estimated 470,000 children in the U.S. are living with epilepsy today, and approximately 30% remain uncontrolled.

    “A single seizure – especially a convulsive seizure – can have devastating effects on many different areas of patient and caregiver lives and increases the risk of sudden unexpected death in epilepsy (SUDEP). Pediatric epilepsy has been steadily increasing in the U.S., so the neurology community is excited to see FYCOMPA become a potential new option to serve this population,” said Jesus Eric Piña-Garza, M.D., Pediatric Neurologist, Tri-Star Medical Group Children’s Specialists. “FYCOMPA’s long, 105-hour half-life and unique mechanism of action may benefit young patients and their physicians looking for a new mono- or adjunctive therapy option as they continue toward their goals of reaching seizure freedom.”

    Eisai is seeking approval for pediatric use based on a 2018 Draft Guidance noting the FDA’s current thinking regarding clinical development programs that can support extrapolation of the effectiveness of drugs approved for the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 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 study enrolled 180 patients –148 with POS and 32 with PGTC seizures – with an overall mean daily dose of 6 mg.

    The primary objective of Study 311 was safety and tolerability, evaluated based on incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), laboratory parameters, vital signs, and ECG parameters. Secondary endpoints included the efficacy of perampanel as measured by the median percent change per 28 days in seizure frequency, by the proportion of responders (≥25% , ≥50%, and ≥75%), and by the proportion of subjects who are seizure-free for POS, PGTC, and secondarily generalized tonic-clonic (SGTC) seizures as well as the effects of perampanel on cognition, behavior, visuomotor skills, and growth and development in children during short-term (23 weeks) and long-term (up to 52 weeks) treatment.

    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.

    “Children today are busy. Whether it is schoolwork, practicing a musical instrument or sports – we love to see young patients take on challenges and demonstrate that epilepsy is a challenge they can tackle,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “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.”

    FYCOMPA, the first and only seizure medication that targets the AMPA receptor, was initially approved for adjunctive use in POS in 2012 and has been approved in 55 countries worldwide. FYCOMPA was approved for adjunctive use in patients with PGTC seizures in 2015 and as monotherapy use for the treatment of POS in 2017. An oral suspension formulation was also approved in 2016.

    About Epilepsy
    Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, which affects about 3.4 million people in the United States, including 470,000 children. Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures.  Generalized seizures account for approximately 40 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of generalized seizures. 

    Convulsive seizures can cause significant injury to patients from falling down suddenly and are the most important risk factor associated with sudden unexpected death in epilepsy (SUDEP), making them one of the most severe forms of epileptic seizures.

    About FYCOMPA
    FYCOMPA is a once-daily prescription medicine used in people with epilepsy aged 12 and older:

    • alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures
    • with other medicines to treat primary generalized tonic-clonic seizures

    FYCOMPA, a unique oral medication, is a selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown.

    FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets, and in an oral suspension formulation. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII).

    Official Notifiaction


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