Biogen brings the gospel to Alzheimer's disease for the first time since 2003...

On June 7, 2021, the FDA approved Biogen's highly controversial Aduhelm (aducanumab) for the treatment of Alzheimer's disease/Alzheimer's disease

Aduhelm is the first new treatment for Alzheimer's disease approved since 2003, and it is also the first treatment for the basic pathophysiology of Alzheimer's disease

Aduhelm’s prescribing information includes warnings about amyloid-related imaging abnormalities (ARIA), which are usually manifested as temporary swelling of brain regions that usually disappear over time without causing symptoms, although some people may have headaches , Confusion, dizziness, vision changes or nausea

Researchers evaluated the efficacy of Aduhelm in three independent studies (3482 patients in total)

According to the terms of accelerated approval, the FDA requires Biogen to conduct a new randomized controlled clinical trial to verify the clinical efficacy of the drug

In the previous months, there has been heated debate about whether Aduhelm is really effective in treating Alzheimer's disease

In the November 2020 vote, the FDA advisory committee voted whether there is "strong evidence" showing that antibodies delayed cognitive decline in clinical phase 3 studies, 8 votes against, 1 vote for, and 2 votes for uncertainty.

Maria Carrillo, chief scientific officer of the Alzheimer's Association, supported the approval of the drug

The FDA approval may be a positive signal from Biogen’s competitor Eli Lilly, who also has his own Alzheimer’s disease drug candidate donanemab, which is also a monoclonal antibody against amyloid plaques