Eisai Co.,\u00a0Ltd.\u00a0(Headquarters: Tokyo, CEO: Haruo Naito,\u00a0“Eisai”)\u00a0announced today thatEisai received\u00a0a\u00a0New Drug Approval for\u00a0its in-house\u00a0discovered\u00a0and\u00a0developed\u00a0antiepileptic drug (AED)\u00a0Fycompa\u00ae\u00a0(perampanel)\u00a0from the China National Medical Products Administration (NMPA) for use in\u00a0an adjunctive\u00a0treatment\u00a0of\u00a0partial onset seizures\u00a0(with or without secondarily generalized seizures)in epilepsy patients\u00a012 years of age and older.\u00a0Fycompa\u00a0was\u00a0designated for Priority Review by\u00a0the\u00a0NMPA\u00a0due to\u00a0itssignificant\u00a0clinical benefits\u00a0compared to existing treatments,\u00a0and\u00a0was\u00a0approved in about 12\u00a0months since\u00a0the\u00a0submission in\u00a0September\u00a02018.<\/p>\n
In China, it is estimated that there are approximately 9 million patients with epilepsy, approximately 60%\u00a0of whom\u00a0being affected by\u00a0partial-onset seizures.\u00a0About\u00a040%\u00a0patients with partial-onset seizures\u00a0require\u00a0adjunctive treatment.1<\/sup>As approximately30% of patients with epilepsy are unable to control their seizures\u00a0with currently available AEDs,\u00a02<\/sup>this is a disease with significant unmet medical needs.<\/p>\n Fycompa\u00a0is a first-in-class AED discovered at Eisai\u2019s Tsukuba Research Laboratories. Administered orally\u00a0once-daily, it is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal\u00a0hyperexcitation\u00a0associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic\u00a0membranes.<\/p>\n Fycompa\u00a0has been approved in over\u00a060\u00a0countries around the world as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in\u00a0patients with\u00a0epilepsy\u00a012 years of age\u00a0and older. In addition,\u00a0Fycompa\u00a0has been approved in over 55\u00a0countries as an adjunctive treatment for\u00a0primary generalized tonic-clonic seizures in patients\u00a0with epilepsy\u00a012 years of age and older. In\u00a0the United\u00a0States,\u00a0Fycompa\u00a0is also indicated for monotherapy and adjunctive use in the treatment of partial-onset\u00a0seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.<\/p>\n Eisai considers neurology including epilepsy, a therapeutic area of focus. With this approval of Fycompa\u00a0in China, Eisai\u00a0pursues our mission to provide\u00a0“seizure freedom”\u00a0to a greater number of patients\u00a0with\u00a0epilepsy\u00a0across the world\u00a0living. Eisai\u00a0seeks to address the diverse needs of, as well as increasing the\u00a0benefits provided to, patients with epilepsy and their families.<\/p>\n Media Inquiries:<\/strong> Eisai Co.,\u00a0Ltd.\u00a0(Headquarters: Tokyo, CEO: Haruo Naito,\u00a0“Eisai”)\u00a0announced today thatEisai received\u00a0a\u00a0New Drug Approval for\u00a0its in-house\u00a0discovered\u00a0and\u00a0developed\u00a0antiepileptic drug (AED)\u00a0Fycompa\u00ae\u00a0(perampanel)\u00a0from the China National Medical Products Administration (NMPA) for use in\u00a0an adjunctive\u00a0treatment\u00a0of\u00a0partial onset seizures\u00a0(with or without secondarily generalized seizures)in epilepsy patients\u00a012 years of age and older.\u00a0Fycompa\u00a0was\u00a0designated for Priority Review by\u00a0the\u00a0NMPA\u00a0due to\u00a0itssignificant\u00a0clinical benefits\u00a0compared to existing treatments,\u00a0and\u00a0was\u00a0approved in about 12\u00a0months since\u00a0the\u00a0submission in\u00a0September\u00a02018.<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28],"tags":[],"class_list":["post-2904","post","type-post","status-publish","format-standard","hentry","category-news-en"],"_links":{"self":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/2904"}],"collection":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/comments?post=2904"}],"version-history":[{"count":2,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/2904\/revisions"}],"predecessor-version":[{"id":2906,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/2904\/revisions\/2906"}],"wp:attachment":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/media?parent=2904"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/categories?post=2904"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/tags?post=2904"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nPublic Relations Department,
\nEisai Co., Ltd.
\n+81-(0)3-3817-5120<\/p>\n","protected":false},"excerpt":{"rendered":"