FDA Grants Fast Track Designation to Posdinemab for Early Alzheimer's Disease

The US FDA has granted Fast Track designations to Johnson & Johnson’s posdinemab, a phosphorylated tau–directed monoclonal antibody (mAb) investigational therapy for early Alzheimer’s disease (AD), according to a company news release.¹

“Posdinemab has the potential to slow the spread of tau pathology in the brain, which may slow cognitive decline,” Bill Martin, PhD, global therapeutic area head, neuroscience, Johnson & Johnson Innovative Medicine, said in the statement. “The FDA’s Fast Track designation reflects the urgent unmet need for new treatment options for the millions living with AD.”¹

Posdinemab is under investigation in the phase 2b AuTonomy trial (NCT04619420) for patients with early AD. According to J&J, the mAb binds to pathological phosphorylated tau and neutralizes it prior to propagation to other neurons. The drug's potential has been demonstrated in cerebrospinal fluid from adults treated for AD. In nonclinical models, the therapy has shown potential to limit tau seeding and spread. The AuTonomy trial is fully enrolled and ongoing.¹

The company is also investigating JNJ-2056, an anti-tau active immunotherapy that received Fast Track designation in mid-2024. JNJ-2056 is being evaluated in the phase 2b ReTain trial (NCT06544616), which is enrolling patients with preclinical AD who exhibit tau pathology but have no cognitive impairment. JNJ-2056 is designed to activate the immune system to produce antibodies against pathological phosphorylated tau, with the goal of delaying or preventing symptom onset, J&J said.¹

Globally, an estimated 55 million individuals live with dementia, approximately 60% to 80% of whom have AD.² Early AD encompasses mild cognitive impairment due to AD and mild dementia. Disease progression includes accumulating cognitive deficits, difficulty performing daily tasks, and eventual dependence on full-time care.²

References

1. Johnson & Johnson's posdinemab and tau active immunotherapy receive USFDA fast track designations for the treatment of Alzheimer's disease. Press release. Johnson & Johnson. January 8, 2025. Accessed January 8, 2025. 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
2. 2024 Alzheimer’s disease facts and figures. Alzheimer's Association. Accessed January 8, 2025. https://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf