Two weeks after the FDA gave the nod to aducanumab, the aftershocks continue to reverberate. Critics are lambasting the agency, three members of its advisory committee resigned, and the drug’s cost has ignited calls for pricing reform. Meanwhile, Alzheimerologists are split, with some applauding the first disease-modifying therapy and others worrying it could dampen research into other drugs. All bemoan the broad label and agree that the drug’s clinical rollout will be challenging.
Series
Fallout Continues After Aducanumab Approval
Aducanumab Approval Sparks Backlash
Eds. note, 25 Jun 2021: In the three days since this series posted, Senators Elizabeth Warren (D, Massachusetts) and Bill Cassidy (R, Louisiana) have ...
A New Era of Alzheimer’s Treatment
The Food and Drug Administration’s decision to greenlight aducanumab (trade name Aduhelm) for Alzheimer’s disease has touched off an explosion of criticism and debate (see Part ...
How Will Aducanumab Approval Change Clinical Practice?
The U.S. Food and Drug Administration’s green light for aducanumab (Aduhelm) is poised to upend research and clinical practice. In research settings, many scientists wonder if this decision will set a precedent for future approvals without proof...
With Little Data to Go On, Clinicians Are Left To Figure Out Way Forward
The FDA’s approval of aducanumab has given Alzheimer’s physicians a new treatment option, but little guidance on how to put it into practice. Clinicians are debating issues such as when to prescribe, who qualifies, and how to ramp up capacity ...