Regulatory Affairs, Northeastern University, Boston, MA 02115, United States
Research
Aducanumab for Alzheimer's disease: A regulatory perspective
Author(s): 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 regulato.. View More»
DOI:
10.4172/25725130.23.8(05).1000253
