News | May 08, 2009

Siemens Applies to FDA for New Imaging Agent for Amyloid Plaques

May 8, 2009 – Siemens Healthcare has filed an exploratory Investigational New Drug (eIND) application with the FDA for a new imaging agent [18F]-SMIBR-W372, to image amyloid plaque associated with Alzheimer's Disease.
The latest result of Siemens broad PET biomarker research program, this new plaque imaging agent, when imaged using positron emission tomography (PET), has been designed to seek out amyloid plaques in the living human brain. Together with other agents developed in the program, [18F]-SMIBR-W372 may assist Siemens in achieving its goal of diagnosing Alzheimer’s disease in its earliest stages.
Through Siemens Molecular Imaging Biomarker Research Center in Culver City, Calif., the company is actively investigating tools that may support a more personalized approach to medicine. Imaging biomarkers not only enable early diagnosis, but also allow the measurement of how well certain therapies, such as prescription drugs, chemotherapy and radiation therapy, are working by measuring the impact of treatments on the disease indicators. This may aid the development of new therapies, and enable clinicians to noninvasively assess therapeutic responses and quickly adjust therapeutic approaches to arrive at optimum outcomes.
The exploratory eIND application with the FDA has been filed under Siemens Medical Solutions USA Inc.

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