by Editor 10/2020
The first treatment for Alzheimers may be on the horizon with Biogen's recent filing with the FDA for aducanumab. The US Food and Drug Administration (FDA) panel is set to review Biogen’s Alzheimer’s disease treatment aducanumab on 6 November.
The meeting of the Peripheral and Central Nervous System Drugs Advisory Committee is set to provide advice and recommendations based on the biologics license application submitted by Biogen for aducanumab.
The experimental Alzheimer’s therapy was initially scrapped after an independent data monitoring committee recommended halting the trials after determining the drug couldn’t slow the rate of disease progression in participants.
However, Biogen surprised investors when it announced that a closer analysis of a subset of patients in the phase 3 EMERGE study found that patients who received sufficient exposure to high doses of the drug experienced benefits on measures of cognition and function, including memory, orientation and language.
Biogen maintained that the failure of aducanumab in a second trial – ENGAGE – was most likely due to the fact that there weren’t a sufficient number of patients receiving enough exposure to the higher dose of the medication.
More than five million Americans are living with Alzheimer’s disease, and that number is estimated to jump to 16 million by 2050 as people live longer and baby boomers reach the age when they are more at risk of the disease
Two out of every 3 people globally believe there is little or no understanding of dementia in their countries. The impact of World Alzheimer's Month is growing, but the stigmatization and misinformation that surrounds dementia remains a global problem that requires global action.