Leqembi authorization in EU is delayed for procedural issues
2024-03-22
加速审批
The EU review of Eisai’s Alzheimer’s drug lecanemab was delayed this week because of a procedural issue at the European Medicines Agency.
On Friday, Eisai said
that a March 19 question-and-answer session on lecanemab at the Committee for Medicinal Products for Human Use (CHMP) didn’t end up happening because of a separate legal issue that came days before.
The delay is related to a court case between D&A Pharma and the EMA. The Court of Justice of the European Union’s ruling on the case from March 14 has “implications on EMA’s policy on the handling of competing interests of experts” in scientific advisory groups that provide advice to help evaluate drugs, according to Eisai.
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
适应症
-靶点
-药物
热门报告
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。