欧盟专家组对罕见病药物给出负面意见后，Zevra股价暴跌

路透中文

Jul 24

BUZZ-欧盟专家组对罕见病药物给出负面意见后，Zevra股价暴跌

7月24日 - ** 制药公司 Zevra Therapeutics（ZVRA.O）的股价在盘前交易中下跌 31.2%，至 8.64 美元

** 欧洲药品管理局（EMA）的药物评估委员会（CHMP） (link) 对Zevra Therapeutics公司提交的阿利莫克洛莫尔（arimoclomol）上市申请作出了否定意见，称该疗法的疗效尚未得到充分证实

** 该公司此前正寻求批准该药物用于治疗尼曼-皮克病C型，这是一种罕见的遗传性疾病，会导致脂肪物质在细胞内堆积，进而对大脑和其他器官造成进行性损伤

** Zevra表示，计划根据欧盟监管流程申请对CHMP的决定进行复审，并将继续通过其全球扩大使用计划（Expanded Access Program）为符合条件的患者提供阿利莫克洛莫尔 (link)

** Zevra丹麦分公司可在收到决定后15天内，就CHMP的否定意见提出复审申请

** 美国食品药品监督管理局（FDA）于2024年批准了阿利莫克洛莫尔（商品名为Miplyffa，详见 (link)），作为该病症的首个治疗药物，最高剂量的年治疗费用略高于100万美元（详见 (link)）

** 截至上一交易日收盘，该股年内累计上涨39.7%

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