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Home » ALS hope could be delayed following negative adcom vote for Amylyx
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ALS hope could be delayed following negative adcom vote for Amylyx

March 30, 2022
By Mari Serebrov
Unless the U.S. FDA once again overrides its Peripheral and Central Nervous System Drugs Advisory Committee, it looks like the ALS community will have a longer wait for an additional tool against the fatal, degenerative disease. After hearing from both Amylyx Pharmaceuticals Inc. and FDA reviewers, along with 26 people testifying during the open public hearing, the committee voted March 30 against approval of AMX-0035, a fixed-dose combination of sodium phenylbutyrate and taurursodiol, as a much-needed treatment for amyotrophic lateral sclerosis (ALS).
BioWorld Regulatory Neurology/psychiatric U.S. FDA

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