Amylyx Pharmaceuticals said Tuesday that the Food and Drug Administration is bringing together a panel of outside experts for a second time to review new data on the company’s experimental treatment for ALS.
The FDA’s decision to schedule a second advisory panel for the Amylyx drug, called AMX0035, is unusual, particularly during the same review period. The expert panel will meet on Sept. 7, Amylyx said.
The move suggests FDA officials are still debating whether to grant accelerated approval to AMX0035 now, with the requirement that Amylyx confirm the treatment’s benefit for patients with results from an ongoing Phase 3 study expected in 2024.
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