Aducanumab's contested approval (2021)
The FDA approved the anti-amyloid drug aducanumab (Aduhelm) despite an advisory panel voting against it. Several panel members resigned in protest. The drug cleared plaques but showed unclear benefit for memory.
Insurers restricted coverage and the rollout largely failed. Its maker later pulled the drug from the market.
The episode hardened doubts that clearing amyloid alone reliably helps patients, opening room for other targets.
The tipping-point study offers an answer to that doubt: the immune response to plaques, not the plaques alone, may decide who declines.
