In June 2021, the US Food and Drug Administration (FDA) granted accelerated approval of aducanumab, a monoclonal antibody against β-amyloid for treatment of early Alzheimer disease. The approval generated significant backlash due to unclear evidence of the drug’s clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an opaque approval process that, per one congressional inquiry, was “rife with irregularities.”
Source: JAMA Online First