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# FDA Fast Track for J&J Alzheimer’s Drug
- URL: https://www.fdaweb.com/fda-fast-track-for-j-j-alzheimers-drug/
- Published: 2025-01-08T12:00:00.000Z
- Updated: 2026-09-14T14:50:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158451

FDA has granted fast-track designation for Johnson & Johnson’s posdinemab which is being investigated in the Phase 2b AuTonomy study to treat patients with early Alzheimer’s disease. A company [statement](https://www.investor.jnj.com/news/news-details/2025/Johnson--Johnsons-Posdinemab-and-Tau-Active-Immunotherapy-Receive-U.S.-FDA-Fast-Track-Designations-for-the-Treatment-of-Alzheimers-Disease/default.aspx?ref=fdaweb.com) says posdinemab is a phosphorylate tau-directed monoclonal antibody that was discovered internally and has shown the 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.