4 June 2021 - In the coming days the FDA will make one of its most important — and controversial — decisions of the year: whether or not to approve aducanumab, an Alzheimer’s drug developed by Biogen. 

It’s rare that an FDA decision is so contentious: the debate over whether aducanumab should be approved has split patients, doctors, advocacy groups and financial analysts. While some say the drug is crucially needed for Alzheimer’s patients with dementia, others say there is not enough evidence to back up this potential new treatment. 

Either way, it is a watershed moment for the FDA, which will redefine how much proof of effectiveness is needed before a drug is approved.

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