Johnson & Johnson on Wednesday said it has won Food and Drug Administration fast-track designation for its proposed posdinemab treatment for Alzheimer's disease.
J&J is investigating the internally discovered tau-directed monoclonal antibody in a Phase 2b study of patients with early Alzheimer's.
The New Brunswick, N.J., pharmaceutical giant said posdinemab has shown 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 the memory-robbing disease.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
The FDA last year granted fast-track designation to J&J's anti-tau active immunotherapy JNJ-2056.
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