Addendum: Aducanumab (Aduhelm) for Alzheimer ' s Disease

Date: July 26, 2021
Issue #: 
1629Summary: 
In June 2021, the FDA approved the IV amyloid beta-directed
monoclonal antibody aducanumab(Aduhelm) for treatment
of Alzheimer ’s disease. The approval did not restrict use of
the drug to patients with mild cognitive impairment or mild
dementia, which was the population enrolled in the clinical
trials. Now, Biogen, with the permission of the FDA, has made
an addition to the labeling of the drug that says:Treatment with
Aduhelm should be initiated in patients with mild cognitive
impairment or mild dementia stage of disease, the population
in which treatment was initiated in clinical trials. There are no
safety or effectiveness data on initiating treatment at earlier or
later stages of the disease than were studied.

Source: The Medical Letter - July 9, 2021 Category: Drugs & Pharmacology Authors: admin Tags: aducanumab Aduhelm Alzheimer ' s disease Source Type: research