Accelerated Approval of Highly Expensive Disease-Modifying Agents:
Lessons to Learn from the Aducanumab Approval.
There were many previous examples of disease-modifying expensive agents
accelerated approval by The US Food and Drug Administration (FDA), which
have been failed to show any clinical effectiveness in confirmatory
trials in patients, subsequently withdrawn from the market. Recently on
June 7th 2021, The FDA has issued an accelerated approval to a highly
expensive disease-modifying agent aducanumab. In the present study, we
will explore the challenges to address and lessons to learn from the
approval of aducanumab another highly expensive only disease-modifying
agent for Alzheimer’s disease.