Biogen's aducanumab, a potential first-of-its-kind drug to slow cognitive decline in Alzheimer's disease, faces a U.S. Food and Drug Administration (FDA) decision by June 7. The drug targets early-stage dementia by attacking amyloid beta plaques in the brain.
Clinical trials were halted midway in 2016 after initial results suggested they would not meet goals. However, updated data from one trial showed a 22% reduction in cognitive decline, prompting Biogen to seek approval. Critics argue the evidence is insufficient and that a third trial is needed.
Supporters, including the Alzheimer's Association, view the drug as a crucial step forward. 'This will give us a new biological foothold to build on,' said Dr. Stephen Salloway of Butler Hospital. They acknowledge the drug is not a cure but could provide temporary benefits for early-stage patients.
Opponents warn of high costs—estimated at $50,000 per patient annually—and potential waste of resources. 'The worst thing for people with Alzheimer's would be to put out a product that doesn't work,' said Harvard's Aaron Kesselheim. The FDA's decision could set a precedent for future Alzheimer's treatments.
