A copy of the anti-epileptic drug Fycompa (perampanel, Verlampane) was submitted to THE EMA

recently, Eisai, a Japanese drugmaker, announced that it had submitted an application to the EuropeanMedicines(http://Authority (EMA) for the anti-epileptic drug Fycompa (perampana) to approve Fycompa for the treatment of pediatric epilepsy patientsIn Europe, Fycompa has been approved for the treatment of partial seizure seclampsia (POS, with or without secondary systemic seizures) and primary all-round strong direct syllone (PGTC) seizures in patients aged 12 and overThe application is intended to expand Fycompa's indications to cover the paediatric patient populationrelated studies
the application is based on data from Phase III Clinical Studies (Study 311) and Phase II Clinical Studies (Study 232), which evaluated Fycompa as an assisted therapy for pediatric epilepsy patientsThe Study 311 study assessed the relationship between the safety, tolerability, efficacy and blood concentration of pediatric patients (4 to 12 years of age) whowere partial or severe spasms as an complementary therapyThe Study 232 study assessed the pharmacokinetics, efficacy and long-term safety of Fycompa as an complementary therapy for pediatric patients (2 to 12 years of age)Detailed results of the two studies will be presented at the upcoming medicalconference(http://FycompaFycompa is a first-in-the-
drug developed internally by Isaito (http://(AEDs), a highly selective, non-competitive AMPA-type glutamate receptor antagonistOn the drug side, Fycompa tablets are taken orally once a day before bedtimeIn addition, Fycompa oral suspension has also been approved by the United StatesTo date, Fycompa has been approved by more than 55 countries worldwide as an complementary therapy for partial seizure seclampsia (POS, with or without a secondary systemic seizure) in people 12 years of age and olderin addition, Fycompa has been approved in more than 50 countries worldwide as an adjunct therapy for the treatment of primary, total strong orthodontic (PGTC) seizures in people 12 years of age and olderIn the United States, Fycompa is also used as a single drug therapy and complementary therapy for partial seizures (with or without a secondary systemic seizure) in people with epilepsy 4 years and olderAt the end of January, Aishi also submitted a supplementary application to Japanese regulators seeking approval of Fycompa as a single-drug therapy for partial seizure sactic epilepsy in pediatric epilepsy patients 4 years and olderIn addition, Aoki has also submitted a new fine particle preparation for FycompaCurrently, Aisiis is also conducting a global Phase III clinical study (Study 338) to evaluate Fycompa's treatment of Lennox-Gastaut syndrome-related epilepsy