Eisai's Anti-Epileptic Drug Fycompa Receives NMPA Acceptance for Two Supplementary New Drug Applications in China

October 19, 2020 /BioonBIOON/ -- Eisai recently announced that the China National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for the next-generation antiepileptic drug Fycompa (Weiketai; generic name: perampanel): (1) as monotherapy for the treatment of partial-onset seizures; and (2) for a pediatric indication: for the treatment of partial-onset seizures in epilepsy patients aged ≥4 years.

Fycompa (perampanel) was approved in China in September 2019 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 people with epilepsy in China. Although seizures can occur at any age, the onset is most common among individuals aged 18 years and younger and in the elderly population. Approximately 30% of patients with epilepsy do not achieve seizure control with currently available antiepileptic drugs (AEDs), indicating a significant unmet medical need in this field.

The sNDA for monotherapy in the treatment of partial-onset seizures is based on subgroup analyses evaluating the safety and efficacy of monotherapy in patients aged ≥12 years with partial-onset seizures (with or without secondary generalization), derived from global adjunctive therapy clinical studies (Studies 304, 305, 306, and 335) conducted in the United States, Europe, and China. In addition, results from the Phase 3 clinical study (FREEDOM/Study 342) conducted in Japan and South Korea were submitted as supplementary safety and efficacy data, involving untreated epilepsy patients aged 12–74 years (with or without secondary generalized seizures).

The sNDA for pediatric patients with partial-onset seizures is based on the results of the Phase III clinical study of Fycompa (Study 311), which evaluated adjunctive therapy in children aged 4 to under 12 years with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures worldwide.

Fycompa (perampanel) is a first-in-class antiepileptic drug (AED) developed internally by Eisai, administered as a once-daily tablet. In the United States and the European Union, a new oral suspension formulation of Fycompa has been approved for marketing. Fycompa is a highly selective, non-competitive antagonist of AMPA-type glutamate receptors. Glutamate is the primary neurotransmitter mediating seizures. As an AMPA receptor antagonist, Fycompa reduces the hyperexcitability of seizure-associated neurons by targeting postsynaptic AMPA receptor–glutamate activity; this mechanism of action differs from that of currently marketed antiepileptic drugs (AEDs).

To date, Fycompa has been approved in more than 70 countries and regions worldwide, including Japan, the United States, China, and other European and Asian countries, as an adjunctive therapy for the treatment of partial-onset seizures (POS), with or without secondary generalization, in patients aged 12 years and older with epilepsy. In addition, Fycompa has been approved in more than 65 countries globally, 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 aged 12 years and older with epilepsy. In Japan, the United States, and South Korea, Fycompa is also approved as monotherapy and adjunctive therapy for the treatment of partial-onset seizures (with or without secondary generalization) in patients aged 4 years and older with epilepsy.

Fycompa is available in multiple formulations and is administered orally once daily at bedtime. Tablets and fine granule formulations have been approved in Japan, while the oral suspension and tablets have received approval in the United States and Europe. To date, Fycompa has been used to treat more than 300,000 patients worldwide across all indications. Currently, Eisai is conducting a global Phase III clinical study (Study 338) to evaluate the efficacy of Fycompa in treating epilepsy associated with Lennox-Gastaut syndrome. Additionally, Eisai is developing an injectable formulation of Fycompa.

Original Source: Supplementary New Drugapplications For Anti-Epileptic Drug Fycompa As Monotherapy For Partial-Onset Seizures, Pediatric Indication For Partial-Onset Seizures Accepted In China