Eisai Launches FYCOMPA® (Perampanel) in China for Adjunctive Treatment of Partial-Onset Seizures in Patients Aged 12 and Older

January 06, 2020/BioValleyBIOON/--Japanese pharmaceutical company Eisai recently announced the launch in China of its next-generation anti-epileptic drug, Fycompa® (generic name: perampanel), a once-daily oral tablet indicated as adjunctive therapy for partial-onset seizures (with or without secondary generalization) in patients aged 12 years and older. The New Drug Application (NDA) for Fycompa was submitted in September 2018. 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.

It is estimated that there are approximately 9 million patients with epilepsy 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 anti-epileptic drugs (AEDs), indicating a significant unmet medical need in this field.

Fycompa 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 60 countries worldwide 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. Additionally, Fycompa has been approved in more than 60 countries worldwide as an adjunctive therapy for the treatment of primary generalized tonic-clonic (PGTC) seizures in patients aged 12 years and older with epilepsy. In the United States, Fycompa is also indicated as both 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. Currently, Eisai is conducting a global Phase III clinical study (Study 338) to evaluate Fycompa for the treatment of epilepsy associated with Lennox-Gastaut syndrome.

Epilepsy is one of the most common neurological disorders worldwide, affecting approximately 3.4 million people in the United States, 1 million in Japan, 6 million in Europe, and 9 million in China, with a global total of around 60 million patients. Approximately 30% of patients fail to achieve seizure control with commercially available antiepileptic drugs (AEDs), indicating a substantial 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, represent the most common and severe form of generalized epilepsy, comprising 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, clonic movements of the limbs, and screaming; in severe cases, urinary and fecal incontinence and status epilepticus may occur. Seizures result from an imbalance between neuronal excitation and inhibition in the brain, which may be triggered by various neurochemical mechanisms, although current understanding remains limited. (Bioon.com)

Original Source:FYCOMPA® FOR ADJUNCTIVE TREATMENT OF PARTIAL ONSET SEIZURES LAUNCHED IN CHINA