Zydus Lifesciences, on Wednesday announced that the USFDA has granted Orphan Drug Designation (ODD) to Usnoflast

Zydus Lifesciences周三，美国食品药品监督管理局（USFDA）宣布资格认定（奇数）至创新

NLRP3 inhibitor, for the treatment of a rare disease called amyotrophic lateral sclerosis

NLRP3抑制剂，用于治疗一种罕见的疾病，称为肌萎缩侧索硬化症

The USFDA's Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the US.

美国食品和药物管理局孤儿药品办公室授予孤儿地位，以支持开发用于治疗罕见疾病的药物，这些罕见疾病影响美国不到20万人。

“This Orphan Drug Designation from the USFDA underlines the urgent need to develop Usnoflast to address Amyotrophic Lateral Sclerosis (ALS), which is a fatal neurodegenerative disease,' said Zydus' chairman Pankaj Patel.

“美国食品药品监督管理局（USFDA）指定的这一孤儿药突显了迫切需要开发乌司司司他来解决肌萎缩侧索硬化症（ALS），这是一种致命的神经退行性疾病，”Zydus主席Pankaj Patel说。

People living with ALS have an average survival of approximately two to five years from diagnosis, with most ALS patients dying from respiratory failure. ALS patients experience neuroinflammation and rapid neurodegeneration. ALS affects approximately 32,000 people in US and on an average 5,000 new patients are diagnosed every year with this disease in USA as per statistics from Centre for Disease Control and Prevention (CDC).

ALS患者的平均生存期约为2至5年，大多数ALS患者死于呼吸衰竭。ALS患者经历神经炎症和快速神经变性。根据疾病控制与预防中心（CDC）的统计数据，ALS在美国影响大约32000人，平均每年有5000名新患者被诊断出患有这种疾病。

More than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an estimated 75,000 people living with ALS..

据估计，欧洲（欧盟和英国）有30000多人患有ALS，而印度估计有75000人患有ALS。。

Usnoflast (ZYIL1) is a novel, oral small molecule NLRP3 inhibitor. Usnoflast has been studied in several pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel Disease (IBD) and Multiple Sclerosis (MS).

Usnoflast（ZYIL1）是一种新型口服小分子NLRP3抑制剂。Usnoflast已在神经炎症，帕金森病，炎症性肠病（IBD）和多发性硬化症（MS）的几种临床前模型中进行了研究。