Short Wave FDA Approves Aducanumab — A Controversial Drug For Alzheimer's
Jun 25, 2021
Jon Hamilton, NPR science correspondent, dives into the heated debate surrounding aducanumab, a new Alzheimer's drug that has sparked skepticism despite FDA approval. He discusses the drug's controversial journey, from questionable clinical trials to its implications for patients and providers. The conversation touches on the financial burden it imposes and the mixed feelings of hope and doubt among experts. Hamilton also explores how this approval could reshape future Alzheimer's drug development, raising questions about the integrity of regulatory processes.
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Aducanumab's Development and Trials
- Aducanumab, an amyloid drug, targets plaque buildup in Alzheimer's patients' brains.
- Despite initial positive small study results, larger trials were halted due to perceived futility.
Biogen's Early Optimism
- In 2016, Biogen's chief medical officer, Dr. Al Sandrock, expressed cautious optimism about aducanumab.
- He emphasized the need for large trials to confirm early positive indicators, acknowledging potential benefits for millions.
Unusual FDA Approval Pursuit
- Biogen's decision to seek FDA approval despite halted trials surprised scientists.
- Their submission included one positive and one neutral unfinished study, raising concerns.