Eisai's Anti-Epileptic Drug Fycompa Receives Two Additional Approvals from China's NMPA for Monotherapy and Pediatric Use

Eisai recently announced that its internally discovered and developed antiepileptic drug Fycompa® (Weiketai®, generic name: perampanel) has received two additional approvals from China's National Medical Products Administration (NMPA): (1) as a monotherapy for the treatment of partial-onset seizures; and (2) a pediatric indication: as an adjunctive therapy/monotherapy for the treatment of partial-onset seizures in pediatric patients aged ≥4 years with epilepsy.

In China, Fycompa (Weiket'ai) was previously approved for the adjunctive treatment of partial-onset seizures (with or without secondary generalization) in patients with epilepsy aged ≥12 years. With this latest approval, Fycompa is approved in China as both monotherapy and adjunctive therapy for the treatment of partial-onset seizures (with or without secondary generalization) in patients with epilepsy aged ≥4 years.

It is estimated that there are approximately 9 million patients with epilepsy in China, of whom about 60% are affected by focal epilepsy. Among these, 40% of patients with focal epilepsy require adjunctive therapy. Approximately 30% of epilepsy patients fail to achieve seizure control with commercially available antiepileptic drugs (AEDs), underscoring a significant unmet medical need in this field.

The approval of Fycompa as monotherapy for partial-onset seizures is based on the results of subgroup analyses evaluating the safety and efficacy of monotherapy from clinical studies of Fycompa as adjunctive therapy (Studies 304, 305, 306, and 335). These studies were conducted globally (including in the United States, Europe, and China) and enrolled patients aged ≥12 years with partial-onset seizures (with or without secondary generalized seizures). Additionally, results from a Phase 3 clinical study (FREEDOM/Study 342) evaluating the treatment of partial-onset seizures (with or without secondary generalized seizures) in treatment-naïve epilepsy patients aged 12–74 years in Japan and Korea were submitted as supplemental safety and efficacy data for Fycompa monotherapy.

The approval of Fycompa for partial-onset seizures in pediatric patients is based on the results of a Phase 3 clinical study (Study 311). This global study evaluated Fycompa as adjunctive therapy for the treatment of pediatric patients (aged 4 to <12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures (PGTCS).

Perampanel chemical structure (Image source: adooq.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 seizure activity. As an AMPA receptor antagonist, Fycompa reduces excessive neuronal excitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. This mechanism of action differs from that of currently marketed antiepileptic drugs (AEDs).

To date, Fycompa has been approved in over 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. Additionally, Fycompa has also been approved in over 70 countries worldwide, including the United States, Japan, and other European and Asian countries, 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 China, Fycompa is also indicated as both 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. In the European Union, Fycompa is approved for the adjunctive treatment of partial-onset seizures in patients aged 4 years and older, and for the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients aged 7 years and older.

Regarding administration, Fycompa is administered orally once daily at bedtime. Marketed dosage forms include tablets, fine granules, and oral suspension, with availability varying by country. Currently, Eisai is also developing an injectable formulation of Fycompa. To date, Fycompa has been used to treat over 410,000 patients worldwide.

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

In early January 2021, Eisai launched Fycompa (Weiketai®) in the Chinese market. The drug is a once-daily oral tablet indicated for the adjunctive treatment of partial-onset seizures (with or without secondary generalization) in patients aged 12 years and older with epilepsy.

Epilepsy can be broadly classified according to seizure types, with partial seizures accounting for approximately 60% of epilepsy cases and generalized seizures accounting for about 40%. Primary generalized tonic-clonic (PGTC) seizures, also known as grand mal seizures, are the most common and severe type of generalized seizures, comprising approximately 60% of generalized seizure cases. PGTC seizures are characterized by loss of consciousness and generalized convulsions. Typical manifestations of grand mal seizures primarily include foaming at the mouth, upward deviation of the eyes, limb convulsions, and a sudden cry; severe episodes may result in urinary and fecal incontinence or status epilepticus. Seizures result from an imbalance between neuronal excitation and inhibition in the brain. This imbalance may be triggered by various neurochemical mechanisms, which remain poorly understood to date.

Epilepsy is one of the most common neurological disorders worldwide, affecting approximately 60 million patients globally, including roughly 3.4 million in the United States, 1 million in Japan, 6 million in Europe, and 9 million in China. Approximately 30% of patients fail to achieve adequate seizure control with existing antiepileptic drugs (AEDs); therefore, epilepsy remains a condition with a significant unmet medical need. Although the disorder can occur at any age, it predominantly affects individuals aged 18 years and younger, as well as the elderly population. Given the heterogeneity in etiology and clinical manifestations of pediatric epilepsy, patient prognoses vary considerably—encompassing both cases that respond favorably to treatment and those that are refractory. Consequently, individualized treatment strategies should be implemented for these patients.

Source: ANTI-EPILEPTIC DRUG FYCOMPA APPROVED IN CHINA AS MONOTHERAPY FOR PARTIAL-ONSET SEIZURES AND PEDIATRIC INDICATION FOR PARTIAL-ONSET SEIZURES

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