New drugs for children with epilepsy! Vesei Fycompa (Wexter ®, Villenem Panai) has been approved by the European Union to expand the applicable population, has been listed in China!

November 18, 2020 // -- Eisai (Eisai) recently announced that the European Commission (EC) has approved the anti-epileptic drug Fycompa (Wycombe ®, common name: perampanel, erampanae) to expand the applicable population: (1) as an auxiliary therapy for the treatment of partial seizure epilepsy (POS, with or without or without secondary systemic epilepsy) patients, the age range was expanded from 12 years of age and above to 4 years of age and above, and (2) the age range was expanded from 12 years and older to 7 years and older as an auxiliary therapy for patients with primary comprehensive orthopaedic epilepsy (PGTCS).
In mid-October, China's State Drug Administration (NMPA) accepted two applications from Fycompa for complementary new drugs (sNDA) :(1) as a single-drug therapy to treat partial seizures≥;
this EU approval is based on data from Phase III Clinical Studies (Study 311) and Phase II Clinical Studies (Study 232), which evaluated Fycompa as an auxiliary therapy for patients with POS or PGTCS pediatrics.
(1) Study 311 study evaluated Fycompa as an auxiliary therapy for the safety, toerability, efficacy, and blood drug concentration in pediatric patients (4-12 years of age) who were under control by POS or PGTC.
the results showed that Fycompa combined therapy was similar in safety and effectiveness in pediatric patients (4 years of age -12 years of age) with poor POS control.
the most common adverse events observed in the study (the occurrence rate ≥10%) were drowsiness, nasopharyngitis, fever, vomiting, dizziness, influenza and irritability.
(2) Study 232 study evaluated Fycompa's pharmacodynamics, efficacy, and long-term safety as an auxiliary therapy for the treatment of pediatric epilepsy patients (2 to 12 years of age).
adverse events observed in the study (Fycompa group ≥10%) were fever, fatigue, vomiting, irritability, drowsiness, dizziness, and upper respiratory tract infections.
Epilepsy (Photo: biospace.com) Fycompa is the first anti-epileptic drug (AEDs) developed in-house by Aecoline, a highly selective, non-competitive AMPA glutamate-sensitive antagonist.
glutamate is the main neurotransmitter that mediates seizures.
As an AMPA-like antagonist, Fycompa reduces excessive excitability of neurons associated with seizures by targeting the activity of the AMPA-Glutamate after synapses, a mechanism that is different from the anti-epileptic drugs (AEDs) currently on the market.
To date, Fycompa has been approved by more than 70 countries worldwide, including Japan, the United States, China, and other countries in Europe and Asia, as an ancillary therapy for the treatment of partial seizures (POS, with or without secondary systemic seizures) in patients aged 12 and over.
In addition, Fycompa has been approved by more than 65 countries worldwide, including the United States, Japan and other European and Asian countries, as an ancillary therapy for the treatment of primary full-range PGTC seizures in patients with epilepsy aged 12 years and older.
In Japan, the United States and South Korea, Fycompa is also suitable as a single-drug therapy and complementary therapy for the treatment of partial seizures (with or without secondary systemic seizures) in patients 4 years of age and older.
, Fycompa has been used to treat more than 300,000 patients worldwide.
currently, Wesser is also conducting a global Phase III clinical study (Study 338) to evaluate Fycompa's treatment for Lenox-Gastaut syndrome-related epilepsy.
addition, the company is also developing Fycompa an injection preparation.
in China, Fycompa (Wyketay®, common name: perampanel, ville panai) submitted a new drug application (NDA) in September 2018 as an ad ligation therapy to treat partial seizures in patients aged 12 years and older with epilepsy.
China's State Drug Administration (NMPA) granted Fycompa priority examination in January 2019 and Fycompa in September 2019 because of its significant clinical benefits with existing drugs.
In early January this year, Wesser introduced Fycompa (Wycombe ®), a daily tablet for complementary treatment of partial seizure epilepsy (accompanied or not accompanied by secondary systemic epilepsy) in patients aged 12 and over.
estimates, there are about 9 million people with epilepsy in China, about 60% of whom are affected by partial seizures, of which 40% need complementary treatment.
about 30% of people with epilepsy receive marketable anti-epileptic drugs (AEDs) that do not control seizures, there are significantly unsealed medical needs in this area.
epilepsy can be roughly classified according to the type of seizures, of which some seizures account for about 60% of seizure cases, systemic seizures account for about 40%.
primary all-round strong straightness (PGTC) seizures, or grand mal, are the most common and severe types of systemic seizures, accounting for about 60% of systemic seizures.
PGTC seizures to loss of consciousness and systemic convulsions as the characteristics of common seizure symptoms are mainly spitting white foam, two eyes turned over, limbs convulsions, screaming and other serious causes of urination incontinence, continuous seizures and so on.
seizures are the result of imbalances in the brain that stimulate and suppress neurons, which can be triggered by a variety of neurochemical mechanisms, but little is known.
(sic): EISAI RECEIVES appROVAL FOR EVOLV EXPANSION OF ANTI-EPILEPTIC AGENT FYCOMPA FOR USE IN PEDIATRIC PATIENTS