瑞士医学专家接受桑捷拉对Duchenne肌肉萎缩药物AGAMREE的销售许可申请。 Swissmedic accepts Santhera's marketing authorization application for Duchenne muscular dystrophy drug AGAMREE®.

桑德拉制药公司已获得瑞士医药公司的批准, 申请AGAMREE® (瓦莫罗龙) 治疗杜申肌肉发育不良 (DMD) 的营销许可. Santhera Pharmaceuticals has received acceptance from Swissmedic for the marketing authorization application of AGAMREE® (vamorolone) to treat Duchenne muscular dystrophy (DMD). 该机构将根据2023年12月欧盟的批准情况评估该药物,有可能加快这一过程。 The agency will evaluate the drug based on its December 2023 EU approval, potentially expediting the process. 审查结果预计到后期H1-2026或更早时,如果条件得到满足。 Results from the review are anticipated by late H1-2026, or earlier if conditions are met. AGAMREE 是传统皮质类固醇的新型替代品。 AGAMREE serves as a novel alternative to traditional corticosteroids.