On Monday FDA approved Biogen’s aducanumab, brand name Aduhelm, through a program called accelerated approval. Aduhelm is the first new medication for Alzheimer’s disease in nearly two decades. FDA’s decision was welcomed by patients and their families as a long-awaited ray of hope. At the same time the agency’s independent advisory committee and some Alzheimer’s experts said there was not enough evidence that the drug can help patients.
Aduhelm is a monoclonal antibody that targets amyloid, a protein that clumps into plaques in the brains of Alzheimer’s patients and is considered a biomarker of the disease. One thing both critics and supporters of approval agree on is that the drug substantially reduces levels of amyloid. However, reducing amyloid is not the same thing as slowing symptoms of dementia. Over more than two decades of clinical trials, many amyloid-reducing drugs failed to address symptoms, a history that, some experts say, made it especially important that aducanumab’s data be convincing. FDA ordered Biogen to conduct extensive Phase 4 testing to determine Aduhelm’s efficacy post approval and one can only hope that clear evidence for clinical benefit will emerge. As reported by NYT.