Aducanumab is a IgG1 monoclonal antibody therapy that targets amyloid beta (Aβ), aiding in clearance of the Aβ plaques that are a defining molecular feature of Alzheimer's Disease (AD). Controversy erupted in June 2021 when the FDA overruled their own advisory committee and approved aducanumab (Aduhelm, Biogen) for the treatment of AD. Three members of the Peripheral and Central Nervous System Drugs Advisory Committee resigned in protest and the U.S. House of Representatives and other groups are investigating the FDA's decision, including the relationship between the FDA and Biogen, setting the stage for what may be landmark modifications to drug approval.
The Alzheimer's Association estimates that over 6 million Americans are living with AD, and that number is projected to grow to 12.7 million people by the year 2050. The Alzheimer's Association “enthusiastically” welcomed the approval, claiming it as “a victory for people living with AD and their families” (...