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# Scientists Ask How FDA Will Review New Alzheimer Drugs
- URL: https://www.fdaweb.com/scientists-ask-how-fda-will-review-new-alzheimer-drugs/
- Published: 2021-11-16T12:00:00.000Z
- Updated: 2026-09-14T17:22:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150584

With at least two additional ameloyd-β Alzheimer’s drugs in the pipeline, scientists interviewed for a *Nature* [explainer](https://www.nature.com/articles/d41586-021-03410-9?ref=fdaweb.com) are wondering how FDA will review and decide on the drugs’ fate given the furor over its accelerated approval of Biogen’s Aduhelm (aducanumab). “Some researchers think that the \[Aduhelm\] approval will bolster the development of drugs for treating brain disease,” the article says, “but others see it as a blemish on FDA’s integrity and an obstacle to progress.

FDA accelerated its approval of Aduhelm, which is on the market at about $56,000 per year, overruling an agency advisory committee that voted overwhelmingly not to recommend approval.

The article says Lilly expects to finish its application for the antibody donanemab, which works like Aduhelm, in the next few months, leading to an FDA decision in the second half of 2022\. And Eisai is working with Biogen to complete the submission of data for lescanemab.

*Nature* says that following a recent Clinical Trials on Alzheimer’s Disease conference, these are the questions researchers are asking: 

- whether amyloid-lowering drugs help patients;
- when solid data will be available on whether amyloid-β therapies improve cognition;
- whether FDA will approve anti-amyloid antibodies;
- whether FDA will reconvene at advisory committee for upcoming approvals; and
- whether FDA will limit who can be treated with the therapies.