Biohaven Ltd. announced that the

Biohaven Ltd. 宣布

Division of Neurology

神经科部门

1 within

1 在内部

FDA's

FDA的

Office of Neuroscience

神经科学办公室

informed the Company that they are extending the PDUFA date for the troriluzole new drug application (NDA) for the treatment of spinocerebellar ataxia (SCA) by three months to provide time for a full review of

通知公司，他们将把用于治疗脊髓小脑共济失调（SCA）的troriluzole新药申请（NDA）的PDUFA日期延长三个月，以留出时间进行全面审查。

Biohaven's

Biohaven的

recent submissions related to information requests from the FDA.

与FDA信息请求相关的近期提交内容。

Biohaven Ltd. announced that the

Biohaven Ltd. 宣布

Division of Neurology

神经科 отделение

1 within

1 在内部

FDA's

FDA的

Office of Neuroscience

神经科学办公室

informed the Company that they are extending the PDUFA date for the troriluzole new drug application (NDA) for the treatment of spinocerebellar ataxia (SCA) by three months to provide time for a full review of

通知公司，他们将把用于治疗脊髓小脑共济失调（SCA）的troriluzole新药申请（NDA）的PDUFA日期延长三个月，以留出时间进行完整审查。

Biohaven's

Biohaven的

recent submissions related to information requests from the FDA. The Division also informed

近期与FDA信息请求相关的提交。该部门还通知了

Biohaven

生物港

that it is currently planning to hold an advisory committee meeting to discuss the application, but no date has been scheduled. The FDA did not raise any new concerns in the letter. The FDA's decision regarding the NDA is now expected in 4Q 2025.

目前计划召开一个咨询委员会会议来讨论该申请，但尚未确定日期。FDA在信中并未提出任何新的担忧。FDA关于NDA的决定预计将在2025年第四季度做出。

Biohaven previously received Fast-Track, Orphan Drug Designation (ODD) and Priority Review from the FDA regarding troriluzole for SCA. Priority Review designation is assigned to applications for drugs that would offer a significant improvement over other available treatments for a given disorder or would provide a treatment option where none exists.

Biohaven之前因troriluzole治疗SCA获得了FDA的快速通道、孤儿药资格（ODD）和优先审评。优先审评资格被授予那些针对某种疾病能够提供比现有疗法显著改进或在无可用治疗方案的情况下提供治疗选择的药物申请。

In the case of SCA, a rare, genetic, neurodegenerative disease, troriluzole would be the first and only FDA-approved treatment for this life-threatening disorder..

在SCA这种罕见的遗传性神经退行性疾病的情况下，troriluzole将成为首个也是唯一一个获FDA批准的治疗这种致命疾病的方法。

Vlad Coric

弗拉德·科里奇

, M.D., Chairman and Chief Executive Officer of

，医学博士，董事长兼首席执行官

Biohaven

生物港

stated, 'SCA is a devastating neurodegenerative disease that has affected generations of families and has no current approved therapy. We are committed to bringing the first treatment to patients and families affected by SCA. The clinical data presented in the NDA show a highly favorable benefit-risk profile with troriluzole, a once-daily oral pill, slowing disease progression by 50-70%, as measured by the f-SARA scale, and reducing the risk of falls.

陈述道：“SCA是一种毁灭性的神经退行性疾病，已经影响了几代家庭，目前尚无获批的疗法。我们致力于为受SCA影响的患者和家庭带来首个治疗方案。NDA中提交的临床数据显示，troriluzole这种每日一次的口服药具有非常有利的效益-风险特征，能够将疾病进展减缓50-70%（根据f-SARA量表测量），并降低跌倒风险。”

We look forward to a meeting with the advisory committee to discuss troriluzole's potential to improve the lives of individuals with SCA. We are especially grateful to the patients, families, and leading neurologists who participated in our studies over an 8-year period and the broader SCA community and patient advocacy groups, including the .

我们期待与咨询委员会会面，讨论 troriluzole 改善 SCA 患者生活的潜力。我们特别感谢在过去八年中参与我们研究的患者、家属和神经学专家，以及更广泛的 SCA 社区和患者倡导团体，包括 。

National Ataxia Foundation

全国共济失调基金会

, who supported the review of troriluzole as the first potential therapy for SCA.'

`, 他支持对troriluzole作为SCA的首个潜在疗法进行审查。'

Condition:

条件：

Spinocerebellar Ataxia

脊髓小脑性共济失调

Type:

类型：

drug

药物