New drugs for epilepsy! The paediatric indications and fine particle preparation of Weicai fycompa (weiketai ®, pirampanai) were approved in Japan and listed in China in January!

January 24, 2020 / BIOON/ --Eisai recently announced that the application for supplementary new drugs (SNDA) of the antiepileptic drug fycompa has been approved by the Ministry of health, labor and welfare of Japan (MHLW), including fycompa as an additional indication of monotherapy in the treatment of partial epilepsy, fycompa for the treatment of partial epilepsy in children aged 4 and over An additional indication of epilepsy, fycompa, a new fine particle preparation The approval of monotherapy for partial seizure epilepsy is based on data from phase III clinical studies (freedom / study 342) conducted in Japan and South Korea This study is a multicenter, open label, single group study to determine the efficacy and safety of fycompa as a single drug therapy in the first-line treatment of partial epilepsy in 12-74-year-old epilepsy patients, and compare this efficacy and safety with the results of other AED single drug studies The primary end point of the study was the proportion of patients who received a daily dose of 4 mg fycompa in the maintenance period (26 weeks) to achieve no seizure The results showed that the proportion of patients who had achieved no epileptic attack exceeded the efficacy standard and reached the main end point of the study In terms of safety, the most common adverse reactions (≥ 10%) include dizziness, drowsiness, nasopharyngitis and headache, which is consistent with the known safety of fycompa The approval of treatment 4 for partial episodic epilepsy in pediatric patients at random and above is based on the results of phase III clinical studies (study 111) conducted in Japan, the United States and Europe The study was carried out in pediatric patients (4 to 12 years old) with partial seizure or primary generalized tonic clonus (pgtc) seizure who had poor condition control The efficacy and safety of fycompa as adjuvant therapy were evaluated The results showed that the efficacy and safety of fycompa in pediatric patients were similar to those observed in patients aged 12 and over In addition, the additional approval of fycompa fine particle formulations is based on the results of a study on the bioequivalence of fine particles and tablets carried out in Japan Weicai developed the preparation to make it easier for children and patients who have difficulty taking the tablet to take fycompa Epilepsy can be roughly classified according to its seizure types, in which partial seizures account for about 60% of epileptic cases and systemic seizures account for about 40% Primary generalized tonic clonic (pgtc) seizures, or grand mal, are the most common and severe types of generalized seizures, accounting for about 60% of the total seizure cases Pgtc seizures are characterized by loss of consciousness and general convulsions The main symptoms of major epileptic seizures are foaming at the mouth, eyes turning up, limbs twitching, screaming and so on, which can cause incontinence of stool and urine and persistent seizures Epilepsy is the result of the imbalance of brain neurons' stimulation and inhibition These imbalances may be caused by a variety of neurochemical mechanisms, but little is known at present Fycompa is a first in class antiepileptic drug (AEDs) developed by Weicai It is a highly selective and non competitive AMPA type glutamate receptor antagonist Glutamate is the main neurotransmitter of epilepsy As an AMPA receptor antagonist, fycompa can reduce the hyperactivity of epilepsy related neurons by targeting the activity of postsynaptic AMPA receptor glutamate, which is different from the current market antiepileptic drugs (AEDs) Up to now, fycompa has been approved by more than 65 countries in the world As an adjuvant therapy, fycompa is used for the treatment of partial epilepsy (POS, with or without secondary systemic epilepsy) in patients aged 12 and over In addition, fycompa has also been approved by more than 60 countries in the world as an adjuvant therapy for the treatment of primary generalized tonic clonus (pgtc) seizures in patients aged 12 and over In the United States and Japan, fycompa is also suitable as a single drug therapy and adjuvant therapy for partial epilepsy (with or without secondary systemic epilepsy) in patients aged 4 years and over So far, fycompa has been used in more than 270000 patients worldwide At present, Weicai is also carrying out a global phase III clinical study (study 338) to evaluate the treatment of Lennox Gastaut syndrome related epilepsy with fycompa In China, fycompa (weiketai ®, general name: perampanel, pirampanel) submitted a new drug application (NDA) in September 2018 as an adjuvant therapy for partial epilepsy in patients aged 12 years and over Due to its significant clinical benefits with existing drugs, China National Drug Administration (nmpa) granted fycompa priority qualification in January 2019 and approved fycompa in September 2019 At the beginning of January this year, Weicai launched fycompa (weiketai ®) in the Chinese market, which is a tablet taken once a day for the adjuvant treatment of partial seizure epilepsy (with or without secondary systemic epilepsy) in patients aged 12 and over It is estimated that there are about 9 million epileptics in China, about 60% of them are affected by partial epilepsy, and 40% of them need adjuvant treatment About 30% of epileptic patients received AEDs which were available on the market and could not control epileptic seizures, so there was a significant unmet medical demand in this field Original source: approximate of alternative drag fycompa ® in Japan for monotherapy and differential information for partial-onsetting sequences, as well as as a new formulation