ng28南宫抗癫痫药FYCOMPA用于治疗儿童癫痫患者的新药增补申请被美国食药监局授予优先审评

ng28南宫株式会社（总部位于日本东京，现任社长为内藤晴夫，以下简称”ng28南宫”）宣布，美国食药监局（FDA）已接受ng28南宫抗癫痫药?Fycompa（吡仑帕奈）的增补新药申请，并进行审评。该申请旨在获准扩大该药的适用规模，笼罩癫痫部分性爆发和原发性全面性强直阵挛爆发的儿童患者。别的，按FDA的要求，ng28南宫还在《儿童用药书面申请》中提供了针对该抗癫痫新药进行的试验研究。因此，FDA已对该申请授予优先审评，这意味着，审评期仅为6个月�；凇洞Ψ揭┦褂谜吒斗逊ò福≒DUFA）》，FDA审查终了目标日为2018年9月28日。

这一增补新药申请基于一项III期临床研究（311研究）的中期结果和一项II期临床研究（232研究）的结果。两项研究都显示，在儿童患者和12岁及以上患者中，用Fycompa进行加用治疗的宁静性和有效性相似。该申请意在扩大Fycompa在美国的适应症，从目前适用于单药治疗或加用治疗12岁及以上癫痫患者的部分性爆发（伴或不伴继发性全面性爆发），将适用年龄向下扩展至2岁�；谄窕鄣氖�，这一新药增补申请同时争取扩大在儿童中的适应症，使其包括2岁及以上儿童癫痫原发性全面性强直阵挛爆发的加用治疗。

Fycompa是由ng28南宫筑波研究所研发的一种立异型抗癫痫药物。该药是一种高选择性、非竞争性的AMPA型受体拮抗剂，通过靶向突触后AMPA受体的谷氨酸活性，减少与癫痫爆发相关的神经元的太过兴奋。Fycompa已在包括美国在内的多国获批用于加用治疗12岁及以上癫痫患者的部分性爆发（伴或不伴继发性全面性癫痫爆发）和原发性全面性强直痉挛爆发。在美国，Fycompa已批准用于癫痫部分性爆发（伴或不伴继发性全面性癫痫爆发）的单药治疗。一种新开发的口服悬浮制剂也已获批并在美国上市销售。

美国约莫有290万癫痫患者，日本约有100万，欧洲约有600万，而全世界约有6000万癫痫患者。癫痫在各年龄段皆有爆发，在老人和儿童中尤其高发。约莫30%的癫痫患者使用现有的抗癫痫药物不可控制癫痫爆发¹。因此，癫痫仍是一种医疗需求明显未被满足的疾病。

ng28南宫将包括癫痫在内的神经领域作为重点治疗领域，并致力于将Fycompa推广到世界各地，使更多饱受癫痫折磨的患者挣脱癫痫爆发。ng28南宫致力于为满足癫痫患者及其家属的多样化需求，并提高他们的福祉，而作出更大的孝敬。

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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.

“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

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