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The U.S. Food and Drug Administration (FDA) has approved Acadia Pharmaceuticals’ Daybue Stix (trofinetide) for the treatment of Rett syndrome. This marks a significant regulatory milestone for the therapy, which is designed to address this rare neurological disorder that primarily affects females.

美国食品药品监督管理局 (FDA) 已批准 Acadia Pharmaceuticals 的 Daybue Stix（曲芬奈肽）用于治疗 Rett 综合征。这标志着该疗法在监管方面迈出了重要的一步，该疗法旨在应对这种主要影响女性的罕见神经系统疾病。

Rett syndrome is a genetic condition characterized by severe cognitive, motor, and communication impairments. Trofinetide, the active ingredient in Daybue Stix, aims to target the underlying symptoms of the disorder. The FDA’s approval follows a review process that evaluated the safety and efficacy of the treatment based on clinical trial data submitted by Acadia Pharmaceuticals.

雷特综合征是一种以严重认知、运动和沟通障碍为特征的遗传性疾病。Daybue Stix 的活性成分曲非奈肽旨在针对该疾病的潜在症状。FDA 的批准是基于对 Acadia Pharmaceuticals 提交的临床试验数据进行的安全性和有效性评估的审查过程。

This decision provides a new therapeutic option for patients living with Rett syndrome and their caregivers..

这项决定为患有雷特综合症的患者及其护理人员提供了一种新的治疗选择。

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Date: December 15, 2025

日期：2025年12月15日

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2025-12-15

2025年12月15日