FDA Broadens Use of Neuraceq® for Better Alzheimer's Diagnosis and Care

In a significant development for Alzheimer's diagnostics, Life Molecular Imaging, Ltd. (LMI) has announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for Neuraceq® (florbetaben F18 injection). This update expands the scope of the imaging agent to include patient selection for amyloid-directed therapies, integrating quantitative image analysis to enhance the diagnostic process.

Neuraceq® is now approved for broader clinical applications, supporting both diagnostic evaluations and the identification of suitable candidates for FDA-approved amyloid-targeting treatments. This includes employing quantitative metrics for amyloid plaque alongside visual interpretations from positron emission tomography (PET) scans. Additionally, the updated label allows for more extensive use of Neuraceq® in monitoring therapy and tracking the progression of Alzheimer's disease (AD).

Amyloid proteins, when accumulated in the brain, form plaques that can lead to AD. Neuraceq® is specifically designed to bind to these amyloid plaques, allowing clinicians to detect them through PET imaging. This capability aids in assessing whether AD is a contributing factor to a patient's cognitive issues. The revised label aligns with the prescribing information for amyloid-targeting therapeutic products, highlighting the role of amyloid PET scans in evaluating plaque reduction during clinical trials for these therapies.

According to Andrew Stephens, Chief Medical Officer at Life Molecular Imaging, the FDA's decision marks a significant advance in Alzheimer's disease diagnostics. By updating Neuraceq's label to align with the revised Appropriate Use Criteria for amyloid PET, clinicians are better equipped to make informed decisions and identify patients who might benefit from amyloid-targeting treatments, ultimately leading to improved patient outcomes.

The safety profile for Neuraceq® remains unchanged with the new indication. The imaging agent is widely covered by Medicare and many private insurance plans, although coverage specifics can vary. Patients and healthcare providers are advised to verify individual insurance details to confirm coverage.

Neuraceq® is utilized in PET imaging of the brain to estimate the density of amyloid beta neuritic plaque in adults with cognitive impairment. This contributes to evaluating Alzheimer's disease and other cognitive decline causes, as well as selecting patients indicated for amyloid beta-directed therapies, as described in associated therapeutic products' prescribing information.

There are important safety considerations to note. Interpretation errors may occur during Neuraceq® image analysis, particularly if relying on clinical information that hasn't been evaluated for use with Neuraceq® images. Severe brain atrophy and motion artifacts can distort images, complicating the differentiation between gray and white matter. Independent image interpretation, possibly using co-registered anatomical imaging, is recommended to improve accuracy.

Neuraceq® contributes to a patient's overall long-term radiation exposure, which is linked to an increased cancer risk. Proper handling is essential to minimize unintentional radiation exposure to both patients and healthcare providers. Patients should be advised to stay hydrated and frequently void before and after the administration of Neuraceq®.

The safety profile is based on data from 1,090 administrations to 872 subjects, showing no serious adverse reactions related to Neuraceq®. The most common reactions were injection site-related, including pain, erythema, and irritation.

Life Molecular Imaging, a company focused on developing advanced PET radiopharmaceuticals for neurodegenerative and cardiovascular diseases, is committed to innovation in molecular imaging, aiming to improve the detection and understanding of life-threatening diseases for better patient outcomes.