By narrow margin, FDA advisory panel concludes Amylyx ALS drug hasn’t proven effectiveness

For archived live coverage of the hearing of the FDA’s advisory panel, click here.

By a narrow margin, an independent panel of advisers to the Food and Drug Administration on Wednesday decided that data from a single trial of an experimental drug developed by Amylyx Pharmaceuticals were not sufficient to conclude the therapy was an effective treatment against ALS.

The vote was 6-4 — closer than many expected given the FDA’s previously stated position that data from a single clinical trial of the Amylyx drug, called AMX0035, showed only a modest benefit and “may not be sufficiently persuasive” to support approval.

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