Khevna Shah
Background: The most common reason for dementia, which is marked by a continuous decline in mental, behavioral, and social skills and reduces a person's capacity for independent functioning though the uncertainties remain regarding the precise etiology of Alzheimer's. There are 3 stages of the disease- Mild, Moderate, Severe. Aducanumab is a newly developed drug approved for the treatment of Alzheimer's. In June 2021, the FDA approved aducanumab for the treatment of Alzheimer's. This drug was approved on the basis of FDA’s accelerated Pathway
Objective:The study aims to determined the regulatory perspective in development of drug, challenges faced by FDA in drug approval and the clinical trials results.
Methods:Information for this review was gathered from published works as well as publicly available documents from the government and regulatory agencies. Search terms related to aducanumab, immunotherapy, antibodies, anti-beta-amyloid therapy, memory loss, treatment and mild cognitive impairment. Using platforms like Web of Science, Medline, Google Scholar, Pubmed, FDA websites, and the manufacturer's website, clinical trials, reviews, and updates on aducanumab in AD patients have been published.
Results:These preliminary studies of the drug demonstrate its efficacy in decline in amyloid plaque from the brain as well as its potential advantage in delaying cognitive decline in Alzheimer's patients.
Following the phase 1B (PRIME) trial's encouraging findings, two 18-month phase III ENGAGE and EMERGE. The ADCS-ADL scale also revealed a 40% slower rate of functional deterioration as compared to the placebo group, while the Neuropsychiatric Inventory (NPI) test revealed an 87% decrease in behavioral changes from baseline scores, particularly in the EMERGE highdose group. The ENGAGE study, on the other hand, failed to demonstrate any dose-dependent advantage of pharmacological therapy over placebo. The drug is still in the phase 4 trial.
Conclusion:Aducanumab regularly and strongly demonstrated a dose- and time-dependent decrease in the amount of amyloid plaques in the brain. This indication has been given accelerated approval. The controversies surrounding the FDA's approval of aducanumab, however, the issues raised by the FDA's approval of aducanumab significance further investigation in order to restore public confidence in the review process, not only for aducanumab's potential promise but, more importantly, for the upcoming formation of desperately needed disease-modifying therapies for this emerging conditions.