衛(wèi)材株式會社（總部位于日本東京，現(xiàn)任社長為內藤晴夫，以下簡稱”衛(wèi)材”）宣布，美國食藥監(jiān)局（FDA）已接受衛(wèi)材抗癲癇藥?Fycompa（吡侖帕奈）的補充新藥申請，并進行審評。該申請旨在獲準擴大該藥的適用范圍，覆蓋癲癇部分性發(fā)作和原發(fā)性全面性強直陣攣發(fā)作的兒童患者。此外，按FDA的要求，衛(wèi)材還在《兒童用藥書面申請》中提供了針對該抗癲癇新藥進行的試驗研究。因此，F(xiàn)DA已對該申請授予優(yōu)先審評，這意味著，審評期僅為6個月?；凇短幏剿幨褂谜吒顿M法案（PDUFA）》，F(xiàn)DA審查終了目標日為2018年9月28日。

這一補充新藥申請基于一項III期臨床研究（311研究）的中期結果和一項II期臨床研究（232研究）的結果。兩項研究都顯示，在兒童患者和12歲及以上患者中，用Fycompa進行加用治療的安全性和有效性相似。該申請意在擴大Fycompa在美國的適應癥，從目前適用于單藥治療或加用治療12歲及以上癲癇患者的部分性發(fā)作（伴或不伴繼發(fā)性全面性發(fā)作），將適用年齡向下擴展至2歲?；谄穹e累的數據，這一新藥補充申請同時爭取擴大在兒童中的適應癥，使其包括2歲及以上兒童癲癇原發(fā)性全面性強直陣攣發(fā)作的加用治療。

Fycompa是由衛(wèi)材筑波研究所研發(fā)的一種創(chuàng)新型抗癲癇藥物。該藥是一種高選擇性、非競爭性的AMPA型受體拮抗劑，通過靶向突觸后AMPA受體的谷氨酸活性，減少與癲癇發(fā)作相關的神經元的過度興奮。Fycompa已在包括美國在內的多國獲批用于加用治療12歲及以上癲癇患者的部分性發(fā)作（伴或不伴繼發(fā)性全面性癲癇發(fā)作）和原發(fā)性全面性強直痙攣發(fā)作。在美國，F(xiàn)ycompa已批準用于癲癇部分性發(fā)作（伴或不伴繼發(fā)性全面性癲癇發(fā)作）的單藥治療。一種新開發(fā)的口服懸浮制劑也已獲批并在美國上市銷售。

美國大約有290萬癲癇患者，日本約有100萬，歐洲約有600萬，而全世界約有6000萬癲癇患者。癲癇在各年齡段皆有發(fā)生，在老人和兒童中尤其高發(fā)。大約30%的癲癇患者使用現(xiàn)有的抗癲癇藥物不能控制癲癇發(fā)作¹。因此，癲癇仍是一種醫(yī)療需求明顯未被滿足的疾病。

衛(wèi)材將包括癲癇在內的神經領域作為重點治療領域，并致力于將Fycompa推廣到世界各地，使更多飽受癲癇折磨的患者擺脫癲癇發(fā)作。衛(wèi)材致力于為滿足癲癇患者及其家屬的多樣化需求，并提高他們的福祉，而作出更大的貢獻。

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About Study 311
Study 311 is a global (United States, Europe, Japan, Asia) multicenter, open-label, single-arm trial with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of Fycompa oral suspension when administered as an adjunctive therapy in approximately 160 pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
Following the 23 week treatment phase in which patients were titrated to receive 2 to 16 mg of Fycompa orally once-daily, long term safety was assessed during an extension phase. In Japan, pediatric patients with partial-onset seizures were titrated to receive 2 to 12 mg of Fycompa orally once-daily. The adverse events (≥10% in the perampanel arms) observed in Study 311 at the time of interim analysis were somnolence, nasopharyngitis, dizziness, and irritability.

About Study 232
Study 232 was a global (United States, Europe), multicenter, open-label, long-term administration clinical study in approximately 63 pediatric patients with epilepsy (ages 2 to less than 12). The study evaluated the pharmacokinetics, safety, tolerability and efficacy of Fycompa oral suspension taken at the same time as other AEDs. Administration of once-daily Fycompa was titrated from 0.015 mg/kg to 0.18 mg/kg, and long-term safety was confirmed after 11 weeks of treatment and an extension phase (41 weeks). The most common adverse events (≥10% in the perampanel arms) observed in Study 232 were pyrexia, fatigue, vomiting, irritability, somnolence, dizziness, and upper respiratory tract infection.

1. “The Epilepsies and Seizures: Hope Through Research. What are the epilepsies?” National Institute of Neurological Disorders and Stroke, accessed May 24, 2016,http://www.ninds.nih.gov/disorders/epilepsy/detail_epilepsy.htm#230253109