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Fix the process that led to Alzheimer’s drug fiasco

Reforms to accelerated approval should focus on securing reliable information in the present and clinical evidence for the future.
By
  1. Jason Karlawish

    1. Jason Karlawish is a professor of medicine at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia and co-director of the Penn Memory Center. Twitter: @jasonkarlawish

The morning of 7 June 2021 was a shock. The US Food and Drug Administration (FDA) approved aducanumab, the first treatment targeting β-amyloid, a protein associated with Alzheimer’s disease.

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Nature 606, 9 (2022)

doi: https://doi.org/10.1038/d41586-022-01507-3

Competing Interests

J.K. has been a site investigator on clinical trials sponsored by Biogen and Lilly; and is a member of AARP’s Global Council on Brain Health.

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