/PRNewswire/ -- Life Molecular Imaging, Ltd. (LMI) announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Neuraceq

/PRNewswire/ -- Life Molecular Imaging, Ltd. (LMI) 宣布，美国食品药品监督管理局 (FDA) 已批准 Neuraceq 的更新标签。

(florbetaben F18 injection), expanding its indication for selecting patients for amyloid-targeting therapies, as described in the prescribing information of the therapeutic products, and including the utilization of quantitative analysis for positron emission tomography (PET) scans.

（氟贝他苯 F18 注射液），扩展了其用于选择针对淀粉样蛋白治疗的患者的应用范围，正如治疗产品处方信息中所述，并包括利用定量分析进行正电子发射断层扫描 (PET)。

Key updates to the Neuraceq

Neuraceq的关键更新

label include:

标签包括：

Expanded clinical indication to include use in both diagnostic assessment and identification of appropriate candidates for FDA-approved amyloid-targeting therapies.

扩展了临床适应症，以包括在诊断评估和识别适合FDA批准的靶向淀粉样蛋白治疗的适当候选者中的应用。

Utilization of quantitative amyloid plaque metrics in conjunction with visual image interpretation.

结合视觉图像解读的定量淀粉样蛋白斑块指标的利用。

Broader use for monitoring of therapy and following progression to Alzheimer's disease (AD).

更广泛地用于治疗监测和追踪阿尔茨海默病（AD）的进展。

Amyloid, a naturally occurring protein, can accumulate into harmful plaques in the brain, thereby causing AD. Neuraceq

淀粉样蛋白是一种天然存在的蛋白质，会在大脑中积累形成有害的斑块，从而导致阿尔茨海默病。Neuraceq

binds selectively to these plaques, enabling detection via PET imaging. This capability assists clinicians in determining whether or not AD is contributing to a patient's cognitive symptoms, when combined with other diagnostic evaluations. This aligns with the prescribing information of FDA approved amyloid-targeting therapeutic products.

能够有选择性地结合这些斑块，从而通过PET成像进行检测。当结合其他诊断评估时，这种能力有助于临床医生判断AD是否导致患者认知症状的原因。这与FDA批准的靶向淀粉样蛋白治疗产品的处方信息一致。

The clinical studies section now includes that amyloid PET scans have been utilized in certain clinical trials to evaluate reductions in amyloid plaque following treatment with amyloid-targeting therapies..

临床研究部分现在包括了在某些临床试验中使用淀粉样蛋白PET扫描来评估淀粉样蛋白靶向治疗后淀粉样斑块的减少情况。

'This FDA action is a major advancement in Alzheimer's diagnostics,' said

“这一FDA的行动是阿尔茨海默病诊断方面的一项重大进展，”

Andrew Stephens

安德鲁·斯蒂芬斯

, Chief Medical Officer at Life Molecular Imaging. 'Updating the Neuraceq

Life Molecular Imaging的首席医疗官。'更新Neuraceq

label to reflect the revised Appropriate Use Criteria for amyloid PET

反映修订后的淀粉样蛋白PET适当使用标准的标签

enhances clinicians' ability to support patient decision making and identify individuals who may benefit from amyloid-targeting treatment - ultimately contributing to improved patient outcomes.'

增强了临床医生支持患者决策和识别可能受益于靶向淀粉样蛋白治疗的个体的能力——最终有助于改善患者的治疗效果。

The safety profile of Neuraceq

Neuraceq的安全性概况

has been confirmed to remain unchanged with the new indication.

已确认随着新适应症的出现保持不变。

Neuraceq

Neuraceq

PET imaging is widely covered under Medicare and many private insurance plans, although policy specifics can vary. Clinicians and patients are encouraged to verify individual coverage details.

PET成像在Medicare和许多私人保险计划中被广泛覆盖，尽管政策细节可能有所不同。鼓励临床医生和患者核实个人的覆盖细节。

About Neuraceq

关于Neuraceq

(florbetaben F 18 injection)

（氟贝他苯 F 18 注射液）

Indication (approved by FDA on

适应症（经FDA批准

23 June 2025

2025年6月23日

is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:

适用于脑部正电子发射断层扫描（PET），用于评估认知障碍成人患者的β淀粉样蛋白神经炎斑块密度，以：

Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline

阿尔茨海默病（AD）及其他认知衰退原因的评估

Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products

适用于淀粉样蛋白β导向疗法的患者选择，如治疗产品处方信息中所述

About Life Molecular Imaging (LMI)

关于生命分子影像（LMI）

Life Molecular Imaging GmbH, together with its affiliates in the UK and US (LMI) is a radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field.

Life Molecular Imaging GmbH 与其在英国和美国的分公司（LMI）是一家致力于开发和提供用于神经退行性疾病和心血管疾病成像的新型尖端 PET 放射性药物的公司。该组织力求成为分子影像领域的领导者。

Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine.

我们的使命是开创能够改善慢性病和危及生命的疾病早期检测和特征描述的创新PET产品，从而带来更好的治疗效果和生活质量的提升。通过推进用于分子成像的新型PET放射性药物，LMI正专注于现代医学的一个关键领域。