Biogen’s Alzheimer’s drug expected to be approved by the FDA after successful late-stage trial

pharmafile | November 5, 2020 | News story | Business Services  

Biogen’s Alzheimer’s drug aducanumab is on track to be approved by the FDA after a successful late-stage clinical trial. 

The drug targets a beta-amyloid in the brain which researchers hypothesise plays a key role in the disease. 

The FDA released a statement after its advisory council met. The organisation said the latest results from the trial were “highly persuasive”, adding that its “capable of providing the primary contribution to a demonstration of substantial evidence of effectiveness of aducanumab. Based on the considerations above, the applicant has provided substantial evidence of effectiveness to support approval.”

The FDA also said the drug has an acceptable safety profile for Alzheimer’s patients. 

This is a surprising turnaround from last year, when Biogen pulled the plug on the drug after an independent group said it would not work in treating the disease, but told investors they were still seeking approval in October. The FDA’s final decision is expected by March, 

So far, the FDA has approved Alzheimer’s drugs aimed at helping symptoms, but none that slow or reverse the disease itself. Biogen estimates that over a million people could benefit from the drug in the US. 

Conor Kavanagh

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