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# Amylyx ALS Drug May Cause FDA Problems: AP
- URL: https://www.fdaweb.com/amylyx-als-drug-may-cause-fda-problems-ap/
- Published: 2022-03-24T12:00:00.000Z
- Updated: 2026-09-14T17:37:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151445

An Associated Press report on an upcoming advisory committee meeting to consider Amylyx Pharmaceuticals’ investigational amyotrophic lateral sclerosis (ALS) drug says the drug may cause the agency issues similar to those caused by its controversial approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease. Three advisory committee members resigned to protest the agency’s approval of Aduhelm despite an advisory committee recommendation that it not be approved.

The AP report says the agency had told Amylyx it would have to conduct a large, confirmatory study before seeking approval but later relented and said it could submit an application based on the smaller study after “months of intense lobbying by ALS patients and their representatives in Congress.”

The Amylyx drug (sodium phenylbutyrate and taurursodiol) received priority review from FDA and has a PDUFA action date of 6/29.

AP says the willingness to consider the Amylyx application with a smaller study comes at a time when government investigators are looking into the Aduhelm approval, including whether FDA succumbed to pressure from Alzheimer’s disease groups and drug company interests.

“Experts who study FDA decision making see a troubling pattern in which the beleaguered agency is continually pressured to accept weaker evidence, damaging its scientific credibility and opening the door to ineffective treatments,” the story says.

AP says there are significant differences between the two drugs. FDA approved Aduhelm based on laboratory measures suggesting it helped slow cognitive decline, even though company studies failed to demonstrate a significant patient benefit. The ALS drug has demonstrated a measurable improvement in patients but did not affect laboratory results.

The report says experts disagree on the meaning of the study results for patients.