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GW制药领军药Epidiolex三期临床成功,股价立马翻倍!

2016-03-21 佚名 生物谷

伦敦GW制药公司发布公告称,其以大麻提取物为活性成分的epilepsy治疗罕见病Dravet综合征三期临床表现良好。该三期临床结果将大大提高通过FDA批准上市几率。这则重大利好使其股价暴涨一倍多,从38美元一度飙到91美元,让不少投资者乐开了花。 Epidiolex 是一种口服的、高纯度 CBD 提取物液体制剂,CBD 是一种来自大麻植物的非精神类成分,不会引起幻觉。GW坚信该药能减少一

伦敦GW制药公司发布公告称,其以大麻提取物为活性成分的epilepsy治疗罕见病Dravet综合征三期临床表现良好。该三期临床结果将大大提高通过FDA批准上市几率。这则重大利好使其股价暴涨一倍多,从38美元一度飙到91美元,让不少投资者乐开了花。

Epidiolex 是一种口服的、高纯度 CBD 提取物液体制剂,CBD 是一种来自大麻植物的非精神类成分,不会引起幻觉。GW坚信该药能减少一些严重儿童癫痫的痉挛发作。美国 FDA 曾先后授予该公司用于治疗儿童 Lennox-Gastaut 综合征 (LGS) 的药物Epidiolex 孤儿药资格和Dravet 综合征孤儿药资格。

GW称,在治疗罕见病Dravet综合征的三期临床试验中,120名Dravet综合征患者一半给药Epidiolex一半给安慰剂,14周后,病人平均每月发作减少39%,显着高于安慰剂组的13%。

安全性方面,8位病人在临床试验中因副作用退出试验,而安慰剂组只有1位。但是产生副作用的8患者称,副作用较为温和。

公司现在计划会见FDA以推进Epidiolex上市。GW还在开展治疗LGS综合征的三期临床,同时还在计划第三个癫痫类适应症的三期临床。

GW为美国未来市场下了大功夫。去年公司的CEO Justin Gover专门飞去南加州与艾尔建的Julian Gangolli会面商讨该药在北美业务运作,为Epidiolex美国商业运营奠定基础,以推动Epidiolex尽快上市。

LGS 是一种严重形式的儿童发作性癫痫。癫痫发作类型因患者而异,包括强直性发作、失张力发作、非典型失神发作和肌阵挛发作。大多数 LGS 儿童会经历某些程度的智力功能或信息处理功能的损伤,以及发育迟缓和行为障碍。LGS 可由大脑畸形、围产期窒息、严重头部外伤、中枢神经系统感染和遗传退行性或代谢症状引起。据估计,美国大约有 1.4 万 -1.85 万 LGS 患者,欧洲约有 2.3 万 -3.1 万患者。

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    2016-03-22 1de304d2m86(暂无匿称)

    好,学习了

    0

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