STAT+: In reversal, FDA advisers vote a second time to support approval of Amylyx’s drug for ALS
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.
Continue to STAT+ to read the full story…
