Johnson & Johnson’s posdinemab granted FDA Fast Track designation

Johnson & Johnson announced that the U.S. Food and Drug Administration has granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody being investigated to treat patients with early Alzheimer’s disease in the Phase 2b “AuTonomy” study. The internally discovered mAb has shown the potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated AD patients, and in blocking the development and spread of tau aggregates in non-clinical models of disease.