FDA尚未就Agios Pharmaceuticals针对非输血依赖和输血依赖性阿尔法或β地中海贫血成年患者的米他派瓦特补充新药申请发布监管决定，目前仍在审查中。

2025-12-08 20:10

The Prescription Drug User Fee Act (PDUFA) goal date issued by the FDA was December 7, 2025.
Agios is collaborating closely with the FDA to finalize the labeling documents and Risk Evaluation and Mitigation Strategy (REMS) materials. The FDA has not requested, and the company has not submitted, any new or additional efficacy or safety data.
The FDA has not provided a timeline for its regulatory decision. Agios continues to work expeditiously with the FDA to conclude the review of the sNDA.