#USA #FDA Approval #Boston #Alzheimer's #Neuraceq®

FDA Expands Usage of Neuraceq® for Alzheimer's Disease

On July 1, 2025, Life Molecular Imaging, Ltd. (LMI) made an exciting announcement regarding its positron emission tomography (PET) agent, Neuraceq® (florbetaben F18 injection). The U.S. Food and Drug Administration (FDA) has approved updated labeling for this innovative imaging agent, which enhances its indications for selecting patients eligible for amyloid-directed therapies. This significant advancement in Alzheimer's diagnostics promises to elevate the standard of care for patients suffering from this debilitating condition.

Key Updates to Neuraceq® Labeling

The newly approved labeling brings several important changes, including:

• - Expanded clinical indication that now encompasses both diagnostic assessments and the identification of suitable candidates for FDA-approved amyloid-targeting therapies.
• - Utilization of quantitative amyloid plaque metrics in conjunction with visual image interpretation, thus improving diagnostic accuracy.
• - Broader applicability for monitoring patient therapies and tracking disease progression in Alzheimer’s disease (AD).

Amyloid, a protein that can build up into detrimental plaques within the brain, plays a crucial role in Alzheimer's disease. Neuraceq® selectively binds to these plaques, enhancing their visibility during PET imaging. This functionality aids medical practitioners in assessing whether AD is influencing a patient's cognitive decline when combined with other diagnostic tools. Furthermore, clinical trials have demonstrated that amyloid PET scans can be instrumental in evaluating the efficacy of treatment options aimed at reducing amyloid plaque accumulation.

Major Clinical Advancements

According to Andrew Stephens, Chief Medical Officer at Life Molecular Imaging, the FDA’s approval reflects a significant milestone in Alzheimer’s diagnostics. He states, "Updating the Neuraceq® label to integrate the revised Appropriate Use Criteria for amyloid PET markedly improves clinicians’ capacity to guide patient choices and identify individuals who might benefit from treatments aimed at targeting amyloid plaques. This will ultimately lead to better patient outcomes."

The overall safety profile of Neuraceq® remains consistent with previous evaluations, providing reassurance for both clinicians and patients.

Coverage and Accessibility

Neuraceq® PET imaging enjoys broad coverage under Medicare as well as numerous private insurance plans, although the specifics of coverage can differ between providers. It is advisable for clinicians and patients to confirm individual insurance benefits prior to proceeding with the imaging procedure.

About Neuraceq®

Indications (approved by the FDA on June 23, 2025): Neuraceq® is indicated for positron emission tomography (PET) imaging of the brain to evaluate amyloid beta neuritic plaque density in adults who exhibit cognitive impairment. This indication includes:

• - Evaluation of Alzheimer’s disease (AD) and other potential causes of cognitive decline.
• - Selection of patients qualifying for amyloid beta-directed therapies, as outlined in the prescribing information for relevant therapeutic products.

Important Safety Information

While Neuraceq® has shown promise, there are potential risks that need to be addressed:

• - Image Interpretation Errors: Due to various factors such as brain atrophy and motion artifacts, there may be errors when estimating brain amyloid density. Clinicians are encouraged to interpret images independently from clinical data to ensure accuracy.
• - Radiation Risks: Given that Neuraceq® contributes to a patient's cumulative radiation exposure, it is important to ensure proper handling and advise patients on hydration and urination post-administration.
• - Common Adverse Reactions: Based on data from 1,090 administrations, adverse reactions were generally mild, with notables including pain, erythema, and irritation at the injection site.

For full prescribing information, please visit Neuraceq.com.

About Life Molecular Imaging (LMI)

Life Molecular Imaging is a radiopharmaceutical company dedicated to advancing PET radiopharmaceuticals for imaging neurodegenerative and cardiovascular diseases. Through innovative products, LMI aims to enhance early diagnosis and improve treatment outcomes in critical health conditions. As a member of the Life Healthcare group, LMI is in the process of being acquired by Lantheus Holdings, Inc. For more details on the acquisition, visit Life Healthcare News.