At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals.
The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.
The FDA is not required to follow the guidance of its outside advisers, but is highly likely to do so with AMX0035. The agency’s approval decision is expected by the end of September.
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