Aduhelm is the brand name under which the Alzheimer’s drug Aducanumab is marketed. It is developed by the U.S. company Biogen. The drug is to be administered as an intra-venous infusion every four weeks.
The Food and Drug Administration (FDA) approved Aducanumab in June 2021, making it the first Alzheimer’s disease medication approved by the FDA since 2003. It is also the first ever approved Alzheimer’s drug targeting the presence of amyloid beta (a type of protein) plaques in the brain.
However, almost everything about this drug is controversial, from the theory on which the drug is developed, to its clinical trials data, to the FDA approval itself. This article aims to distill the complicated information down to a few points, which might help patients make more informed decisions.
Key Dates Surrounding the FDA Approval of Aducanumab
July 2020: Biogen completes submission of aducanumab data (from previously discontinued clinical trials) to FDA.
November 2020: FDA external advisory committee rejects aducanumab because the data failed to prove the drug’s efficacy in reducing cognitive decline in Alzheimer’s patients.
June 2021: FDA grants accelerated approval for aducanumab for patients of all stages of Alzheimer’s disease, on the condition that Biogen conducts post-approval trials (phase 4 trials) to verify the efficacy of the drug.
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