Amylyx’ Second Chance Advisory Committee: Two Quasi-Precedents

US FDA’s plan to reconvene an advisory committee for a second look at Amylyx’ ALS drug AMX0035 is a remarkable twist in the ongoing review. It is essentially unprecedented, though there are two examples from the 1990s that offer some parallels.

WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)
• Source: Sarah Silbiger/Getty Images (Sarah Silbiger/Getty Images)

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...

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