Amylyx’ Second Chance Advisory Committee: Two Quasi-Precedents

Amylyx Pharmaceuticals, Inc.’s announcement that the US Food & Drug Administration is re-convening the Peripheral & CNS Drugs Advisory Committee for another look at the proposed ALS therapy AMX0035 has plenty of people struggling to think of a precedent for FDA to bring an NDA to an advisory committee twice during the same review cycle. (Also see "Will Amylyx’s ALS Drug Benefit From US FDA’s Aduhelm Experience?" - Pink Sheet, 5 July, 2022.)

There is no shortage of examples of the same application going to an advisory committee more than once. It is just that it usually only happens after the first application is rejected and then resubmitted with new information (or, perhaps, re-argued in the context of a formal appeal)