[Correspondence] The regulatory rollercoaster continues—EMA refuses donanemab
In 2024, the European Medicines Agency (EMA) approved lecanemab for the treatment of early Alzheimer's disease in patients without contraindications or risk factors for side-effects. This approval followed a nearly 2-year review process that involved multiple rounds of evaluation, initial rejections, formal appeals, and ultimately a reversal of the initially negative decision. In February, 2025, the Committee for Medicinal Products for Human Use formally endorsed the approval.1 Although Europe has been tied up in lengthy regulatory procedures, donanemab—another anti-amyloid therapy that has a similar amyloid-clearing effect as lecanemab—was approved in several other parts of the world.
In 2024, the European Medicines Agency (EMA) approved lecanemab for the treatment of early Alzheimer's disease in patients without contraindications or risk factors for side-effects. This approval followed a nearly 2-year review process that involved multiple rounds of evaluation, initial rejections, formal appeals, and ultimately a reversal of the initially negative decision. In February, 2025, the Committee for Medicinal Products for Human Use formally endorsed the approval.1 Although Europe has been tied up in lengthy regulatory procedures, donanemab—another anti-amyloid therapy that has a similar amyloid-clearing effect as lecanemab—was approved in several other parts of the world.
