The new drug supplement application of fycompa, an antiepileptic drug of Weicai, was granted priority review by FDA

Weicai Co., Ltd (headquartered in Tokyo, Japan, and currently president is keifu Endo, hereinafter referred to as "Weicai") announced that the U.S Food and Drug Administration (FDA) has accepted the application for supplementary new drugs of the antiepileptic drug fycompa (pirampana) of Weicai, and has carried out the review The purpose of the application is to be allowed to extend the application of the drug to children with partial seizures and primary generalized tonic clonic seizures In addition, according to the requirements of FDA, Weicai also provided the experimental research on the new antiepileptic drug in the written application for children's medication As a result, FDA has granted priority review to the application, which means that the review period is only six months Based on the prescription drug user payment Act (PDUFA), the FDA's end of review target date is September 28, 2018 This supplementary new drug application is based on the interim results of a phase III clinical study (study 311) and the results of a phase II clinical study (study 232) Both studies showed that the safety and efficacy of adjuvant therapy with fycompa were similar in children and patients aged 12 and over The application is intended to expand the indications of fycompa in the United States, from partial seizures (with or without secondary comprehensive seizures) currently applicable to single drug therapy or adjuvant therapy for epilepsy patients aged 12 and over to 2 years old Based on the data accumulated so far, this new drug supplement application also strives to expand the indications in children, including the auxiliary treatment of primary generalized tonic clonic seizures in children aged 2 and above Fycompa is an innovative antiepileptic drug developed by the Institute of building wave of Weicai The drug is a highly selective and non competitive AMPA receptor antagonist, which can reduce the hyperactivity of neurons related to epilepsy by targeting the glutamate activity of postsynaptic AMPA receptor Fycompa has been approved in many countries, including the United States, to assist the treatment of partial seizures (with or without secondary generalized seizures) and primary generalized tonic seizures in patients aged 12 years and over In the United States, fycompa has been approved for single drug treatment of partial seizures (with or without secondary generalized seizures) A newly developed oral suspension has also been approved and marketed in the United States There are 2.9 million epileptics in the United States, 1 million in Japan, 6 million in Europe, and 60 million in the world Epilepsy occurs in all ages, especially in the elderly and children About 30% of epilepsy patients can't control epilepsy by using existing antiepileptic drugs Therefore, epilepsy is still a disease whose medical needs are obviously not satisfied Weicai takes the neural field including epilepsy as the key treatment field, and is committed to promoting fycompa to all over the world, so that more patients suffering from epilepsy can get rid of epilepsy Weicai is committed to making greater contributions to meet the diversified needs of epileptics and their families and improve their well-being