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Johnson & Johnson Says Investigational Alzheimer's Therapy Receives US FDA 'Fast Track' Designation
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Johnson & Johnson Says Investigational Alzheimer's Therapy Receives US FDA 'Fast Track' Designation
Jan 8, 2025 6:06 AM

08:37 AM EST, 01/08/2025 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Wednesday the US Food and Drug Administration has granted 'Fast Track' designation to posdinemab, an investigational therapy for Alzheimer's disease.

The company said posdinemab, a monoclonal antibody that targets tau protein pathology, is being studied in the phase 2b "AuTonomy" trial for early Alzheimer's disease. It has shown promise in reducing phosphorylated tau in cerebrospinal fluid and in non-clinical models, Johnson & Johnson ( JNJ ) said.

Fast Track designation is intended to accelerate the development and review of treatments for serious conditions with unmet medical needs, the company added.

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