FDA approval of aducanumab (Aduhelm) was contentious. Its submission to Health Canada for approval highlights concerns about evidence, independence and transparency in Canada’s drug approval process.
The new drug is based on the idea that a build-up of amyloid in the brain leads to the disease. But that hypothesis has been under scrutiny lately.
The FDA approved Alzheimer’s disease drug aducanumab despite minimal evidence of its efficacy. Whether this decision ultimately hurts or helps patients depends on data researchers don’t yet have.
After the failure of multiple drug trials the outlook for an Alzheimer’s drug is bleak. This shouldn’t be a surprise. We don’t know the cause or even how to diagnose the disease.
Protein tangles have been blamed for causing Alzheimer’s – but drugs that target them keep failing.