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安斯泰来在日本获得Izervay治疗地理性萎缩的有条件批准

Astellas Pharma Secures Conditional Approval in Japan for Izervay to Treat Geographic Atrophy

GeneOnline 等信源发布 2025-09-22 16:20

可切换为仅中文


Astellas Pharma has obtained conditional approval in Japan for its drug Izervay, designed to suppress the progression of geographic atrophy (GA). The decision marks a significant regulatory milestone for the treatment of this advanced form of age-related macular degeneration, which currently lacks effective therapeutic options..

安斯泰来制药在日本获得了其药物Izervay的有条件批准,该药物旨在抑制地图样萎缩(GA)的进展。这一决定标志着针对这种晚期年龄相关性黄斑变性的治疗取得了重要的监管里程碑,目前该疾病尚无有效的治疗选择。

The approval allows Izervay to be used under specific conditions to address GA, a chronic and progressive condition that leads to irreversible vision loss. Geographic atrophy is characterized by the gradual degeneration of retinal cells, impacting central vision over time. Astellas Pharma’s development of Izervay aims to slow down this deterioration and provide relief for patients affected by the disease.

该批准允许Izervay在特定条件下用于治疗GA,这是一种导致不可逆视力丧失的慢性进行性疾病。地理性萎缩的特点是视网膜细胞逐渐退化,随着时间的推移影响中央视力。安斯泰来制药开发Izervay旨在减缓这种恶化,并为受该疾病影响的患者提供缓解。

Further details regarding clinical trial data or post-approval requirements have not been disclosed at this stage..

目前尚未披露有关临床试验数据或批准后要求的更多细节。