FDA Expands Neuraceq® Label to Support Alzheimer's Treatment Decisions and Monitoring

The U.S. Food and Drug Administration (FDA) has approved significant updates to the labeling of Neuraceq® (florbetaben F18 injection), enhancing its role in diagnosing Alzheimer’s disease (AD) and guiding treatment decisions involving amyloid-targeting therapies. The expanded indication also supports the use of quantitative analysis alongside visual interpretation of PET scans, Life Molecular Imaging (LMI) announced.

Key updates to Neuraceq®'s labeling include:

• Broader diagnostic use: Now indicated not only for assessing amyloid plaques in patients with cognitive impairment but also for selecting individuals eligible for FDA-approved amyloid-targeting treatments.

• Integration of quantitative PET metrics: Allows clinicians to combine visual image interpretation with measured plaque load.

• Monitoring potential: The updated label supports the use of Neuraceq® for tracking therapeutic response and disease progression.

Amyloid plaques—aggregates of a naturally occurring brain protein—are a hallmark of Alzheimer’s disease. Neuraceq® binds to these plaques, enabling clinicians to detect and estimate their density via PET imaging. This helps determine whether AD is contributing to cognitive symptoms, in combination with other clinical assessments. The update aligns with new prescribing guidance for anti-amyloid therapies and reflects their growing role in AD treatment.

“This FDA action is a major advancement in Alzheimer's diagnostics,” said Andrew Stephens, Chief Medical Officer at Life Molecular Imaging. “Updating the Neuraceq® label to reflect the revised Appropriate Use Criteria for amyloid PET enhances clinicians' ability to support patient decision making and identify individuals who may benefit from amyloid-targeting treatment—ultimately contributing to improved patient outcomes.”

The clinical section of the new label now notes that amyloid PET scans have been used in clinical trials to evaluate the effectiveness of treatments that reduce amyloid plaque accumulation.

Importantly, the safety profile of Neuraceq® remains unchanged. Among 1,090 administrations across 872 individuals, the most common side effects were mild injection site reactions such as pain (3.4%), redness (1.7%), and irritation (1.1%). No serious adverse reactions have been reported.

The label also includes cautions about potential risks associated with scan interpretation errors, especially in patients with severe brain atrophy or movement during scanning. The drug adds to cumulative radiation exposure, which is linked to an increased cancer risk, so patients are advised to stay well-hydrated and void frequently post-injection to help minimize exposure.

Neuraceq® is generally covered by Medicare and many private insurance plans, though coverage specifics may vary. Clinicians and patients are encouraged to verify their individual policies.

First approved in June 2025, Neuraceq® is now indicated for brain PET imaging to estimate amyloid beta neuritic plaque density in adults with cognitive decline, both for evaluating Alzheimer’s and for identifying candidates for amyloid beta-directed therapies.