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FDA接受审查灵北和大冢长效精神分裂症药物Abilify Maintena sNDA

2014年5月2日讯 /生物谷BIOON/ --灵北(Lundbeck)和大冢(Otsuka)4月30日宣布,FDA已接受审查长效版精神分裂症药物Abilify Maintena(aripiprazole,阿立哌唑)的补充新药申请(sNDA),sNDA的提交意在扩大Abilify Maintean的药物标签,使该药更广泛的用于处于急性期的精神分裂症患者的治疗。

根据处方药用户收费法(PDUFA),FDA已设定Abilify Maintena审查目标日期为2014年12月7日。

Abilify Maintena sNDA的提交,是基于在住院并经历急性期发作的精神分裂症患者中开展的一项为期12周的临床试验的数据。该项研究达到了改善阳性和阴性症状量表评分表(PANSS)总分的主要疗效终点(p<0.0001)。

此外,研究数据还表明,Abilify Maintena也达到了改善临床总体印象-严重度(CGI-S评分)的关键次要终点(p<0.0001)。

关于Abilify Maintena:

Abilify Maintena(aripiprazole,阿立哌唑)是一种长效版精神分裂症药物,该药为每月一次的肌内注射(IM)剂型药物,用于口服阿立哌唑稳定病情的精神分裂症(schizophrenia)成人患者的维持治疗。目前,Abilify Maintena已获FDA、欧盟、加拿大批准。

防止复发是治疗精神分裂症的关键。支持Abilify Maintena监管文件的关键性研究证明,在精神分裂症的长期治疗中,与安慰剂相比,Abilify Maintena能够降低复发的风险,而且疗效不逊色于口服阿立哌唑。(生物谷Bioon.com)

英文原文:US FDA accepts for review Otsuka and Lundbeck’s sNDA for Abilify Maintena

Danish CNS specialist Lundbeck (LUND: C) and the US subsidiary of Japan’s Otsuka Pharmaceutical (TYO: 4768) revealed that the US Food and Drug Administration has accepted for review a supplemental New Drug Application (sNDA) for the proposed expanded labeling of Abilify Maintena (aripiprazole) for extended-release injectable suspension to support broader use of the drug for treatment of patients in the acute phase of schizophrenia.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of December 7, 2014 to complete its review.

The sNDA submission was based on a 12-week study of patients with schizophrenia hospitalized and experiencing an acute exacerbation of symptoms. The study demonstrated efficacy on the primary endpoint of Positive and Negative Syndrome Scale (PANSS) total score (p<0.0001).

Data showed Abilify Maintena was also effective on the key secondary endpoint of Clinical Global Impressions -Severity (CGI-S score, p<0.0001). The three most common adverse events reported by patients receiving Abilify Maintena were weight gain, headache and akathisia. The full study results have been submitted for publication in a scientific journal.

关键词:精神分裂症药物,灵北,大冢,Abilify Maintena,阿立哌唑

信息来源:生物谷