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FDA批准帕金森突破性药物Nuplazid上市许可

2016-04-30 MedSci MedSci原创

Acadia制药于1993年成立,总部位于圣地亚哥,是一家专注于中枢神经系统疾病的制药公司。近日Acadia在美国监管方面收获好消息,其帕金森药物Nuplazid获得专家委员会支持,有望在美国获批。此次专家咨询委员会以12:2的投票结果赞成Nuplazid (pimavanserin)获批,认为其在帕金森治疗方面的效果大于风险,预计将有可能在今年的5月1日得到FDA的最终审批结果。2014年,FD

Acadia制药于1993年成立,总部位于圣地亚哥,是一家专注于中枢神经系统疾病的制药公司。近日Acadia在美国监管方面收获好消息,其帕金森药物Nuplazid (pimavanserin)获得专家委员会支持,有望在美国获批(Lancet:匹莫范色林或可有效治疗帕金森病患者的精神症状)。


此次专家咨询委员会以12:2的投票结果赞成Nuplazid (pimavanserin)获批,认为其在帕金森治疗方面的效果大于风险,预计将有可能在今年的5月1日得到FDA的最终审批结果。

2014年,FDA授予Nuplazid(pimavanserin)突破性药物资格,希望能够加快审批该药物,以满足缓解帕金森患者出现幻觉、妄想等精神症状。

然而,Nuplazid的审批过程并不是一帆风顺。就在这次投票前,FDA发布了一份简报,质疑Nuplazid在帕金森病的治疗方面是否具有临床意义。特别是FDA要求Acadia采取帕金森病阳性症状评定量表(SAPS-PD)来评估新的临床试验结果,这是此前审批过程中没有的。

总体来说,专家组一致认为Nuplazid的治疗效果有限,但是仍具有积极的临床意义,与不断调整常规用药剂量来控制不自主震颤的症状相比,Nuplazid至少起到了治疗效果。

通常医生会使用多巴胺受体激动剂来缓解帕金森患者的症状,但极有可能引起其它精神症状,因此用药的剂量极难把握。一些非典型的安定类药物通常用于病情严重的帕金森患者,但是与Nuplazid不同的是,这类药物会加剧不自主震颤的风险。

目前Acadia似乎已经胜券在握,为了迎接即将到来的上市,公司计划招聘135名销售代表。

除了帕金森症之外,Acadia还在致力于Nuplazid的其它适应症的上市工作,如阿兹海默症相关的精神症状和精神分裂症。

NUPLAZID™是高选择性5羟色胺受体2A亚型反向激动剂,但没有多巴胺受体活性,因此没有其它精神分裂药物的不自主运动副作用。因为帕金森患者的主要症状是不自主肢体运动,所以去掉这个副作用但保留精神分裂疗效十分重要。但NUPLAZID的三个关键临床只有最后一个达到一级终点,而且91个人使用NUPLAZID的病人中只有7人完全应答,而5人发生严重不良反应,其中一人死亡。NUPLAZID最大的副作用是摔倒事件增加,这对年轻人来说这可能不算严重的副作用,但对老年人来说头晕可以导致摔倒频率上升进而导致骨折甚至内脏损伤,所以可能是个非常严重的问题。

但是据Acadia的统计60%的帕金森病患者有精神分裂并发症,仅美国就约有15-20万这样的患者。而传统的精神分裂不仅同样副作用很大,而且多有不自主运动副作用,令帕金森症状雪上加霜。现在治疗PDP除了低剂量氯氮平之外没有批准药物,但氯氮平也有严重的安全隐患,可导致危险的白细胞数量下降。另外氯氮平有嗜睡副作用。所以NUPLAZID去年获得FDA突破性药物地位,今天12票支持、2票反对认为这个疗效已经非常可靠,而且治疗PDP利大于弊。

NUPLAZID如果上市预计峰值销售可达14亿美元,将成为今年的一个主要上市产品。这对Acadia这样的小公司来说无疑是非常重要的事情。Acadia过去几年如同过山车,股票最高达到过50美元,也曾跌破过1美元。不仅自己的表现大起大落,也赶上整个生物技术泡沫的膨胀和破裂。前两个关键临床试验失败,第三个终于成功并得到FDA的认同可以作为申报证据,但去年因为生产问题又推迟了上市申请。同一天CEO突然离职却没有官方解释,结果导致股票大跌25%。

NUPLAZID是Acadia在90年代用一个叫做R-SAT的筛选模型通过对130,000化合物库的筛选找到,化学结构非常简单。zhaod15羟色胺受体2A亚型反向激动剂是一个非常容易的事情,很多芳香乙胺衍生物都有这个活性。但是R-SAT这个筛选平台却和传统的第二信使筛选有所不同。现在NUPLAZID还在阿尔茨海默躁狂病人的临床试验中,如果5月被批准用于PDP很可能被标签外用于这些同样无药可用的适应症。

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    2016-06-27 bugit
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createdName=1de11f7fm56(暂无匿称), createdTime=Sat Apr 30 20:15:00 CST 2016, time=2016-04-30, status=1, ipAttribution=)]
    2016-09-21 ylzr123

    赞一个!好文章拜读了,认真学习了。

    0

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    2016-10-11 30397615
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    2016-05-02 jjzouyan

    厉害的发现

    0

  8. 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createdName=1de11f7fm56(暂无匿称), createdTime=Sat Apr 30 20:15:00 CST 2016, time=2016-04-30, status=1, ipAttribution=)]
    2016-05-02 jjzouyan

    厉害的发现

    0

  9. 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    2016-05-02 wuxian11528

    真是令人惊喜的发现

    0

  10. 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    2016-04-30 1de11f7fm56(暂无匿称)

    永远期待新发现

    0

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