Eisai's Fycompa (Perampanel) Receives CHMP Positive Opinion for Expanded Use in Pediatric Epilepsy Patients

September 24, 2020 News /BioonBIOON/ -- Eisai recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of an expanded indication for the anti-epileptic drug Fycompa (Wei Ke Tai®, generic name: perampanel): (1) as adjunctive therapy for patients with partial-onset seizures (POS), with or without secondary generalized seizures, expanding the eligible 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 eligible age range from 12 years and older to 7 years and older.

The application to expand the pediatric patient population for Fycompa was submitted to the EMA in February 2019. This application was based on data from a Phase III clinical study (Study 311) and a Phase II clinical study (Study 232), which evaluated Fycompa as an adjunctive therapy for pediatric patients with epilepsy. Study 311 assessed the safety, tolerability, efficacy, and relationship between plasma concentration and response of Fycompa as an adjunctive therapy in pediatric patients (aged 4 years to under 12 years) with partially controlled partial-onset or tonic-clonic seizures. Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of Fycompa as an adjunctive therapy in pediatric patients (aged 2 years to under 12 years).

Fycompa is a first-in-class antiepileptic drug (AED) developed internally 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 neurons associated with seizures 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, 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 the United States and Japan, 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 epilepsy 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 compared to 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 (Vimpat®) in the Chinese market. The drug is a once-daily tablet indicated for the adjunctive treatment of 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 frothing at the mouth, upward deviation of the eyes, convulsions of the limbs, 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. These imbalances may be triggered by various neurochemical mechanisms, which remain poorly understood at present. (Bioon.com)

Original Source: Eisai Receives Positive Opinion From EMA's CHMP On Use Of Antiepileptic Agent Fycompa In Pediatric Patients