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# FDA Advisors to Reconsider Amylyx ALS Drug
- URL: https://www.fdaweb.com/fda-advisors-to-reconsider-amylyx-als-drug/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152234

The FDA Peripheral and Central Nervous System Drugs Advisory Committee will meet on 9/7 to again discuss an Amylyx application for its AMX0035 (sodium phenylbutyrate and taurursodiol) ALS drug that was rejected 6-4 by the committee earlier this year. At that time the committee said Amylyx did not offer conclusive proof that its drug works.

Amylyx [says](http://om/media/amylyx-pharmaceuticals-announces-fda-plan-to-reconvene-advisory-committee-to-review-amx0035-nda-for-the-treatment-of-als-on-september-7-2022?ref=fdaweb.com) the upcoming meeting will center on a set of new analyses constituting a “major amendment” to its application.