On Wednesday, Johnson & Johnson (JNJ) announced that the FDA has granted Fast Track designation to its monoclonal antibody, Posdinema, which is currently being evaluated for the treatment of early-stage Alzheimer's disease in the Phase 2b AuTonomy study.
The Fast Track designation is designed to accelerate the review process for therapies that address serious conditions where there is a significant unmet need.
The study has shown promise in targeting disease-associated phosphorylated tau in the cerebrospinal fluid of Alzheimer's patients undergoing treatment. Additionally, it has been found to inhibit the formation and spread of tau aggregates in non-clinical disease models.
Bill Martin, Global Therapeutic Area Head at J&J Innovative Medicine, stated, "Posdinema has the potential to slow the spread of tau pathology in the brain, which may help slow cognitive decline."
Previously, in July 2024, JNJ-2056, the company's first active immunotherapy targeting tau, was also granted Fast Track designation.
The material has been provided by InstaForex Company - www.instaforex.com
The Fast Track designation is designed to accelerate the review process for therapies that address serious conditions where there is a significant unmet need.
The study has shown promise in targeting disease-associated phosphorylated tau in the cerebrospinal fluid of Alzheimer's patients undergoing treatment. Additionally, it has been found to inhibit the formation and spread of tau aggregates in non-clinical disease models.
Bill Martin, Global Therapeutic Area Head at J&J Innovative Medicine, stated, "Posdinema has the potential to slow the spread of tau pathology in the brain, which may help slow cognitive decline."
Previously, in July 2024, JNJ-2056, the company's first active immunotherapy targeting tau, was also granted Fast Track designation.
The material has been provided by InstaForex Company - www.instaforex.com