梯瓦制药的妥瑞氏综合征疗法获美国FDA优先审评

格隆汇08-19 23:01

梯瓦制药宣布，美国食品药品监督管理局(FDA)已对其提交的妥瑞氏综合征实验性儿童疗法ecopipam上市申请授予优先审评资格。FDA已针对ecopipam新药申请设定目标行动日期，预计为2027年第一季度末。妥瑞氏综合征的特征是儿童时期最初出现的不自主运动和发声抽动，在美国约影响10万名儿童和青少年。公司表示，如果获批，ecopipam将成为十多年来首个获批的妥瑞氏综合征疗法。

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