维莫罗伦：首次获批。
Vamorolone: First Approval.
机构信息
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
出版信息
Drugs. 2024 Jan;84(1):111-117. doi: 10.1007/s40265-023-01986-2.
Vamorolone (AGAMREE) is an oral, selective, dissociative corticosteroid developed by ReveraGen BioPharma and Santhera Pharmaceuticals for the treatment of patients with muscular dystrophy. Vamorolone was approved in October 2023 for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older in the USA and received a positive opinion in the EU in October 2023 for the treatment of DMD in patients 4 years of age and older. This article summarizes the milestones in the development of vamorolone leading to this first approval for DMD.
瓦莫鲁龙（AGAMREE）是一种由 ReveraGen BioPharma 和 Santhera Pharmaceuticals 开发的口服、选择性、分离型皮质类固醇，用于治疗肌营养不良症患者。瓦莫鲁龙于 2023 年 10 月在美国获得批准，用于治疗 2 岁及以上的杜氏肌营养不良症（DMD）患者，并于 2023 年 10 月在欧盟获得积极意见，用于治疗 4 岁及以上的 DMD 患者。本文总结了导致瓦莫鲁龙首次批准用于 DMD 的开发里程碑。
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