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囊性纤维化候选药物SNSP113获得欧盟孤儿药物认定

2019-04-11 不详 网络

SNSP113囊性纤维化孤儿药物认定
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Synspira Therapeutics近日宣布，欧洲药品管理局（EMA）孤儿药品委员会（COMP）已授予该公司的SNSP113以孤儿药物认定。

Synspira Therapeutics近日宣布，欧洲药品管理局（EMA）孤儿药品委员会（COMP）已授予该公司的SNSP113以孤儿药物认定。SNSP113是一种糖聚合物，用于治疗囊性纤维化（CF）患者。SNSP113已于2018年10月获得美国食品和药品监督管理局（FDA）颁发的孤儿药物认定。Synspira总裁兼首席执行官Robert Gallotto说：“凭借美国和欧盟的孤儿药物认定，我们在全球监管战略中取得了重要的里程碑，并致力于推进SNSP113作为治疗这种衰弱性疾病的新方法”。

囊性纤维化是一种遗传性外分泌腺疾病，主要影响胃肠道和呼吸系统，通常具有慢性梗阻性肺部病变、胰腺外分泌功能不良和汗液电解质异常升高的特征。


原始出处：

http://www.firstwordpharma.com/node/1634439#axzz5kmtmGZrh

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    2019-09-21 ms6980045490879608

    #孤儿药物#

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    2019-07-28 yuanming7

    #候选药物#

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    2020-02-27 wolongzxh

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    2019-04-13 若水129

    #孤儿药物认定#

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