Aducanumab is a monoclonal antibody designed to remove the build-up of amyloid plaque from the brain of those affected by dementia. Amyloid plaque is associated with poor brain health and memory problems as it impairs and kills neurons. Pharmaceutical companies have been focusing on developing treatments that remove amyloid plaque as it is thought that it will slow this process.
Reasons for hope
New and emerging evidence from its clinical trials has reversed Biogen's decision to withdraw aducanumab and it is now seeking regulatory approval for its use as a treatment for Alzheimer's disease in trials patients. Reviewing the pooled Biogen trial data indicated a positive dose-response relationship between aducanumab, amount of plaque removal, and cognitive performance. With these findings, the further good news is we can expect renewed pharma interest in neurodegeneration-focussed drug development.
Responding to the data drought
Given the paucity of evidence on the value of amyloid plaque removal as a treatment it is reasonable, and in the public interest, to pursue aducanumab even though the evidence is not beyond question. These new findings come from pooled data from two trials that were discontinued due to a lack of early effects. Although this injects an element of uncertainty, that a dose-response relationship on an established mechanism was found is reassuring. The prospect of a beneficial treatment outweighs this limited uncertainty.
Reassurance for the wary
The decision by Biogen to seek FDA approval for making aducanumab available to previously enrolled trials patients is a responsible next step. It enables researchers to collect further evidence rapidly and does this without prematurely raising expectations from a public eager to see progress.
Overall, this is good news indeed.