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.
Despite its prevalence, there is no cure yet for Alzheimer’s disease, or even a treatment that can reverse or stop progression of the disease. The latest drug for Alzheimer’s disease, AbbVie’s Namenda, was approved nearly two decades ago, and only helps prevent some symptoms. In November 2020, the issue grew even more complicated when an FDA advisory panel reviewed the data and nearly unanimously voted against recommending aducanumab for approval. That decision cratered the company’s stock, though it has since recovered.
Howard Fillit, the chief science officer at the Alzheimer’s Drug Discovery Foundation, says FDA approval “would give hope to patients and might encourage more research.”