AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved VYALEV™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD)..

AbbVie（纽约证券交易所：ABBV）今天宣布，美国食品和药物管理局（FDA）已批准VYALEV™（foscarbidopa和foslevodopa）作为第一个也是唯一一个24小时皮下输注左旋多巴治疗晚期帕金森病（PD）成人运动波动的疗法。。

'For too long, the Parkinson's community has had limited treatment options for advanced disease. Due to the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required,' said Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson's and Movement Disorder Center at the University of South Florida.

“长期以来，帕金森氏病社区对晚期疾病的治疗选择有限。南佛罗里达大学神经病学教授、帕金森病和运动障碍中心主任、MBA医学博士罗伯特·豪泽（RobertA.Hauser）说，由于疾病的进展性，口服药物最终在运动症状控制方面不再有效，可能需要手术治疗。

'This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night.' .

“这种新的非手术治疗方案可以在早上、白天和晚上连续服用左旋多巴。”。

The approval was supported by the pivotal Phase 3, 12-week study evaluating the efficacy of continuous subcutaneous infusion of VYALEV in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR)1, along with a 52-week, open-label study which evaluated the long-term safety and efficacy of VYALEV.2.

该批准得到了关键的3期12周研究的支持，该研究评估了与口服速释卡比多巴/左旋多巴（CD/LD IR）1相比，持续皮下输注VYALEV在成人晚期PD患者中的疗效，以及52周的开放标签研究，该研究评估了VYALEV的长期安全性和有效性。

Findings from the pivotal study showed patients receiving VYALEV demonstrated superior improvement in motor fluctuations, with increased 'on' time without troublesome dyskinesia and decreased 'off' time, compared with oral CD/LD IR.1 'On' time refers to the periods of time when patients are experiencing optimal motor symptom control while 'off' time is when symptoms return.3,4.

关键研究的结果显示，与口服CD/LD IR相比，接受VYALEV治疗的患者在运动波动方面表现出优异的改善，增加了“开启”时间而没有麻烦的运动障碍，减少了“关闭”时间。1“开启”时间是指患者经历最佳运动症状控制的时间段，而“关闭”时间是症状恢复的时间段。

The majority of adverse reactions (ARs) with VYALEV were non-serious and mild or moderate in severity. The most frequent ARs (greater than or equal to 10 percent and greater than CD/LD IR incidence) were infusion site events, hallucinations, and dyskinesia.1,2

VYALEV的大多数不良反应（AR）是非严重的，严重程度为轻度或中度。最常见的ARs（大于或等于10%且大于CD/LD IR发生率）是输注部位事件，幻觉和运动障碍。1,2

'People living with advanced Parkinson's disease experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses,' said Roopal Thakkar, M.D., executive vice president, research & development, and chief scientific officer, AbbVie. 'We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of VYALEV.'.

我们很骄傲地将这项创新带给那些可能通过连续24小时服用VYALEV而从运动症状控制中受益的患者。”。

PD is a progressive and chronic movement disorder resulting in tremor, muscle rigidity, slowness of movement and difficulty with balance resulting from the loss of dopamine-producing brain cells.5

PD是一种进行性和慢性运动障碍，导致震颤，肌肉僵硬，运动缓慢以及由于产生多巴胺的脑细胞的丧失而导致的平衡困难。5

Timing for a patient's access to VYALEV is dependent on their individual insurance plan. Coverage for Medicare patients is expected in the second half of 2025.

患者进入VYALEV的时间取决于他们的个人保险计划。预计2025年下半年将覆盖医疗保险患者。

To learn more about this treatment, people should speak with their prescribing healthcare provider.

要了解更多有关这种治疗的信息，人们应该与他们的处方医疗保健提供者交谈。

About Parkinson's DiseaseMore than 10 million people worldwide are living with Parkinson's disease (PD)6, a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement, and difficulty with balance.5 The motor symptoms of Parkinson's disease begin when approximately 60-80 percent of the dopamine-producing cells in the brain are lost and symptoms continue to worsen slowly over the course of time.7 While there is no known cure for the disease, there are treatments available to help reduce symptoms.7.

关于帕金森氏病，全世界有1000多万人患有帕金森氏病（PD）6，这是一种进行性和慢性神经系统疾病，其特征是震颤，肌肉僵硬，运动缓慢和平衡困难。帕金森氏病的运动症状始于大脑中约60-80%的多巴胺产生细胞丢失，症状随着时间的推移继续缓慢恶化。7虽然目前尚无已知的治疗方法，但有治疗方法可以帮助减轻症状。

As PD progresses, patients experience complications, including motor and non-motor fluctuations and dyskinesia. Patients report switching from an 'on' state (when symptoms are generally well controlled) to an 'off' state, during which symptoms such as tremor and stiffness may reappear and patients have more difficulty moving.4 Patients with advanced PD may also experience dyskinesia (involuntary movements) which can significantly hinder daily activities.4 Neuronal degeneration and fluctuating plasma levodopa levels are responsible for the onset of these motor complications, with 50 percent of patients reporting them two to five years after diagnosis and approximately 80-100 percent of patients presenting with them after 10 years.8.

随着PD的进展，患者会出现并发症，包括运动和非运动波动以及运动障碍。患者报告从“开”状态（症状通常得到很好的控制）转变为“关”状态，在此期间，震颤和僵硬等症状可能再次出现，患者移动困难更大。4晚期PD患者也可能出现运动障碍（不自主运动），这可能会显着阻碍日常活动。神经元变性和血浆左旋多巴水平波动是这些运动并发症发生的原因，50%的患者在诊断后2至5年报告，约80-100%的患者在10年后出现。

About the Phase 3 M15-736 Study1The Phase 3 randomized, double-blind, double-dummy, active-controlled study compared the efficacy, safety and tolerability of VYALEV to oral CD/LD IR in patients with advanced PD. Participants were provided with a home diary (the PD Diary) to assess their motor state during the day.

关于第三阶段M15-736研究1第三阶段随机，双盲，双模拟，主动对照研究比较了VYALEV与晚期PD患者口服CD/LD IR的疗效，安全性和耐受性。参与者被提供了一个家庭日记（PD日记）来评估他们白天的运动状态。

The primary endpoint of good 'on' time (defined as 'on' time without dyskinesia plus 'on' time with non-troublesome dyskinesia), was collected and averaged over three consecutive days and normalized to a typical 16-hour waking period. Baseline values are defined as the average of normalized good 'on' time collected over the three PD Diary days before randomization.

收集良好“开启”时间的主要终点（定义为无运动障碍的“开启”时间加上无麻烦运动障碍的“开启”时间），并连续三天取平均值，并标准化为典型的16小时清醒期。基线值定义为随机化前三天PD日记中收集的标准化良好“开启”时间的平均值。

Approximately 130 adult participants with advanced PD were enrolled in the study across 80 sites in the U.S. and Australia. Participants were randomized 1:1 to receive either the VYALEV solution as a continuous delivery under the skin (subcutaneous) plus oral placebo capsules for CD/LD or oral capsules containing CD/LD IR plus continuous subcutaneous delivery of placebo solution for VYALEV.

在美国和澳大利亚的80个地点，大约130名患有晚期PD的成年参与者参加了这项研究。参与者以1:1的比例随机接受VYALEV溶液作为皮肤下（皮下）连续递送加口服安慰剂胶囊用于CD/LD或含有CD/LD IR的口服胶囊加上连续皮下递送安慰剂溶液用于VYALEV。

The treatment duration was 12 weeks. The increase in 'on' time without troublesome dyskinesia at week 12 was 2.72 hours for VYALEV versus 0.97 hours for oral CD/LD IR (p=0.0083). Improvements in 'on' time were observed as early as the first week and persisted throughout the 12 weeks. More information on the study can be found on www.clinicaltrials.gov (NCT04380142) and in The Lancet Neurology (https://doi.org/10.1016/S1474-4422(22)00400-8)..

治疗时间为12周。在第12周，VYALEV的“开启”时间增加了2.72小时，而口服CD/LD IR的“开启”时间增加了0.97小时（p=0.0083）。早在第一周就观察到“开启”时间的改善，并在整个12周内持续存在。有关这项研究的更多信息，请访问www.clinicaltrials.gov（NCT04380142）和《柳叶刀神经病学》(https://doi.org/10.1016/S1474-4422（22）00400-8）。。

About VYALEV™VYALEV (foscarbidopa and foslevodopa) is a solution of carbidopa and levodopa prodrugs for 24-hour continuous subcutaneous infusion for the treatment of motor fluctuations in adults with advanced PD. VYALEV, also known as PRODUODOPA®, has been approved in 35 countries and over 4,200 patients worldwide have started treatment.

关于VYALEV™VYALEV（foscarbidopa和foslevodopa）是一种卡比多巴和左旋多巴前药的溶液，用于24小时连续皮下输注，用于治疗晚期PD成人的运动波动。VYALEV，也称为PRODUODOPA®，已在35个国家获得批准，全世界已有4200多名患者开始治疗。

AbbVie continues to work with regulatory authorities around the world to bring VYALEV to people living with advanced Parkinson's disease..

艾伯维将继续与世界各地的监管机构合作，为晚期帕金森病患者提供 VYALEV。

About AbbVie in Neuroscience At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future.

关于AbbVie 在AbbVie的神经科学，我们对保护世界各地患有神经和精神疾病的人的人格的承诺是坚定不移的。凭借30多年的神经科学经验，我们今天正在提供有意义的治疗选择，并推动未来的创新。

AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders.

AbbVie的神经科学投资组合包括批准的神经疾病治疗，包括偏头痛，运动障碍和精神疾病，以及强大的转化疗法。我们在研究方面进行了大量投资，并致力于加深对神经和精神疾病的了解。

Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information, visit www.abbvie.com..

每一个挑战都使我们更有决心，并促使我们为那些受这些疾病影响的人、他们的护理合作伙伴和临床医生发现并提供进步。有关更多信息，请访问www.abbvie.com。。

About  AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

AbbVie AbbVie的使命是发现并提供创新药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们致力于在几个关键治疗领域（免疫学、肿瘤学、神经科学和眼部护理）以及Allergan美学产品组合中的产品和服务，对人们的生活产生重大影响。