For the first time: an Alzheimer's drug has been approved by the US Food and Drug Administration (FDA).
Studies have shown that the drug lowers the rate of clinical withdrawal in early-stage Alzheimer's patients.
The drug has been approved by the U.S. Food and Drug Administration despite opposition from the FDA's independent advisory committee and some Alzheimer's experts who say there is not enough evidence that the drug can help patients.
The drug, Aducanumab, which will go by the brand name Aduhelm, is an intravenous infusion given once a month and is designed to slow down cognitive decline in people with mild memory and cognitive problems. This is the first treatment approved to attack the disease process of Alzheimer’s instead of just treating dementia symptoms and the first drug approved to fight Alzheimer's since 2003.
Recognizing that clinical trials of the drug provided evidence to prove its efficacy, the FDA approved the use provided the manufacturer, Biogen, performed a new clinical trial.
During the next few years until the end of the trial, the drug will be available to patients. If the post-trial study does not prove the drug's efficacy, the FDA can but is not required to revoke the approval it has given.