Teva Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational therapy emrusolmin (TEV-56286) for the treatment of Multiple System Atrophy (MSA).

梯瓦制药公司宣布，美国食品和药物管理局 (FDA) 已授予其在研疗法emrusolmin (TEV-56286)用于治疗多系统萎缩症 (MSA) 的快速通道资格。

MSA is a rare and progressive neurodegenerative disease with no available cure. It is classified as an atypical parkinsonism and is part of the group of disorders known as synucleinopathies. The condition is caused by abnormal deposits of the α-synuclein protein, mainly in glial cells, leading to severe autonomic dysfunction and movement disorders such as parkinsonian symptoms, ataxia, and speech difficulties..

多系统萎缩（MSA）是一种罕见的、进展性的神经退行性疾病，目前尚无治愈方法。它被归类为非典型帕金森综合征，属于突触核蛋白病这一疾病组。该病由α-突触核蛋白在胶质细胞中的异常沉积引起，导致严重的自主神经功能障碍和运动障碍，例如帕金森样症状、共济失调以及言语困难。

Emrusolmin is designed to target pathological alpha-synuclein oligomers, aiming to address the underlying disease process. The Fast Track designation is intended to speed up the development and review of treatments for serious conditions with high unmet medical needs, supporting progress towards potential new options for people affected by MSA..

Emrusolmin旨在靶向病理性α-突触核蛋白寡聚体，以解决潜在的疾病过程。快速通道资格旨在加速针对高未满足医疗需求的严重病症的治疗方法的开发和审查，为受MSA影响的人群提供潜在的新选择支持进展。

Emrusolmin is being developed through a collaboration with German biotech company MODAG GmbH and is currently in a Phase 2 clinical trial assessing its efficacy and safety. The therapy had previously received Orphan Drug designation from the FDA in 2022.

Emrusolmin正在与德国生物技术公司MODAG GmbH合作开发，目前正处于评估其疗效和安全性的二期临床试验阶段。该疗法此前在2022年获得了FDA的孤儿药资格认定。

The disease affects around 40,000 people in the US, EU, and Japan, with approximately 6,000 new cases identified each year.

该疾病在美国、欧盟和日本影响约 40,000 人，每年大约发现 6,000 例新病例。

Life expectancy after diagnosis is usually between seven and ten years. Current treatment options are limited to symptom management, highlighting the urgent need for new therapies.

诊断后的预期寿命通常为七到十年。目前的治疗选择仅限于症状管理，突显了对新疗法的迫切需求。

Source: tevapharm.com

来源：tevapharm.com