On 8 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted Fast Track designation to its posdinemab. Posdinemab is a phosphorylated tau-directed monoclonal antibody being investigated to treat patients with early Alzheimer’s disease in the Phase 2b “AuTonomy” study.
According to J&J, the drug has demonstrated potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated Alzheimer’s patients, and in blocking the development and spread of tau aggregates in non-clinical models of disease.