Eisai's Fycompa (Perampanel) Receives EU Approval for Expanded Pediatric Use and Is Now Available in China

November 18, 2020 /Bio ValleyBIOON/ -- Eisai recently announced that the European Commission (EC) has approved an expansion of the indicated population for the antiepileptic drug Fycompa® (perampanel): (1) as adjunctive therapy for patients with partial-onset seizures (POS), with or without secondary generalization, expanding the age range from 12 years and older to 4 years and older; and (2) as adjunctive therapy for patients with primary generalized tonic-clonic seizures (PGTCS), expanding the age range from 12 years and older to 7 years and older.

In mid-October this year, the National Medical Products Administration (NMPA) of China accepted two supplemental new drug applications (sNDAs) for Fycompa: (1) as monotherapy for the treatment of partial-onset seizures; and (2) a pediatric indication for the treatment of partial-onset seizures in patients with epilepsy aged ≥4 years.

This EU approval is based on data from the Phase III clinical study (Study 311) and the Phase II clinical study (Study 232), which evaluated Fycompa as an adjunctive therapy for pediatric patients with partial-onset seizures (POS) or primary generalized tonic-clonic seizures (PGTCS). (1) Study 311 assessed the safety, tolerability, efficacy, and relationship between efficacy and plasma concentration of Fycompa as an adjunctive therapy in pediatric patients (aged 4 to <12 years) with inadequately controlled POS or PGTCS. The results demonstrated that the safety and efficacy of Fycompa adjunctive therapy in pediatric patients (aged 4 to <12 years) with inadequately controlled POS were similar to those in patients aged 12 years and older. The most commonly observed adverse events (incidence ≥10%) in this study were somnolence, nasopharyngitis, pyrexia, vomiting, dizziness, influenza, and irritability. (2) Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of Fycompa as an adjunctive therapy in pediatric epilepsy patients (aged 2 to <12 years). The adverse events observed in this study (≥10% in the Fycompa group) were pyrexia, fatigue, vomiting, irritability, somnolence, dizziness, and upper respiratory tract infection.

Epilepsy (Image source: biospace.com)

Fycompa is a first-in-class antiepileptic drug (AED) developed in-house by Eisai. It is a highly selective, non-competitive AMPA-type glutamate receptor antagonist. Glutamate is the primary neurotransmitter mediating seizures. As an AMPA receptor antagonist, Fycompa reduces the hyperexcitability of seizure-related neurons by targeting the activity of postsynaptic AMPA receptors and glutamate; this mechanism of action differs from that of currently marketed antiepileptic drugs (AEDs).

To date, Fycompa has been approved in more than 70 countries worldwide, including Japan, the United States, China, and other countries in Europe and Asia, as an adjunctive therapy for the treatment of partial-onset seizures (POS), with or without secondary generalization, in patients with epilepsy aged 12 years and older. In addition, Fycompa has been approved in more than 65 countries worldwide, including the United States, Japan, and other countries in Europe and Asia, as an adjunctive therapy for the treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy aged 12 years and older. In Japan, the United States, and South Korea, Fycompa is also indicated as monotherapy and adjunctive therapy for the treatment of partial-onset seizures (with or without secondary generalization) in patients with epilepsy aged 4 years and older. To date, Fycompa has been used to treat more than 300,000 patients worldwide.

Currently, Eisai is also conducting a global Phase III clinical study (Study 338) to evaluate the efficacy of Fycompa in the treatment of seizures associated with Lennox-Gastaut syndrome. In addition, the company is developing an injectable formulation of Fycompa.

In China, Fycompa (Wei Ke Tai®, generic name: perampanel) submitted a New Drug Application (NDA) in September 2018 as an adjunctive therapy for partial-onset seizures in patients with epilepsy aged 12 years and older. Due to its significant clinical benefits over existing medications, the National Medical Products Administration (NMPA) of China granted Fycompa priority review status in January 2019 and approved it in September 2019.

In early January this year, Eisai launched Fycompa (Fycompa®) in the Chinese market. This medication is a once-daily tablet indicated as adjunctive therapy for partial-onset seizures (with or without secondary generalization) in patients aged 12 years and older with epilepsy.

It is estimated that there are approximately 9 million epilepsy patients in China, with about 60% affected by focal seizures. Among these, 40% of patients with focal seizures require adjunctive therapy. Approximately 30% of epilepsy patients do not achieve seizure control with currently available antiepileptic drugs (AEDs), indicating a significant unmet medical need in this field.

Epilepsy can be broadly classified according to seizure type, with partial (focal) seizures accounting for approximately 60% of cases and generalized seizures for about 40%. Primary generalized tonic-clonic (PGTC) seizures, also known as grand mal seizures, are the most common and severe type of generalized seizure, representing roughly 60% of all generalized seizure cases. PGTC seizures are characterized by loss of consciousness and generalized convulsions. Common manifestations of grand mal seizures include foaming at the mouth, upward deviation of the eyes, limb convulsions, and screaming; in severe cases, they may lead to urinary and fecal incontinence and status epilepticus. Seizures result from an imbalance between neuronal excitation and inhibition in the brain. Although this imbalance may be triggered by various neurochemical mechanisms, current understanding remains limited. (Bioon.com)

Original Source: EISAI RECEIVESappROVAL FOR INDICATION EXPANSION OF ANTI-EPILEPTIC AGENT FYCOMPA FOR USE IN PEDIATRIC PATIENTS