Madrigal Pharmaceuticals 的 3 期 MAESTRO-NASH 试验结果显示 resmetirom 满足主要终点,有可能成为 FDA 审查和批准的第一个 NASH 治疗药物。 Madrigal Pharmaceuticals' Phase 3 MAESTRO-NASH trial results show resmetirom meeting primary endpoints, potentially becoming the first NASH treatment upon FDA review and approval.
Madrigal Pharmaceuticals 已在《新英格兰医学杂志》上发表了 resmetirom 的 3 期 MAESTRO-NASH 试验结果。 Madrigal Pharmaceuticals has published Phase 3 MAESTRO-NASH trial results for resmetirom in the New England Journal of Medicine. Resmetirom 被审查为第一个 NASH 治疗药物,它实现了 NASH 消退且纤维化不恶化以及纤维化减少且 NAFLD 活动评分 (NAS) 不恶化的主要终点。 Resmetirom, under review to be the first NASH treatment, achieved primary endpoints of NASH resolution with no worsening of fibrosis, and fibrosis reduction with no worsening of NAFLD activity score (NAS). FDA 已授予优先审查权并批准处方药使用者收费法案 (PDUFA),日期为 2024 年 3 月 14 日。 FDA has granted Priority Review and a Prescription Drug User Fee Act (PDUFA) date of March 14, 2024. 如果获得批准,瑞美罗可能会彻底改变 NASH 治疗,成为该疾病的第一种药物疗法。 If approved, resmetirom could revolutionize NASH treatment as the first pharmacological therapy for the disease.