Justin Klee (L) and Josh Cohen (Amylyx)
Adcomm votes 7-2 in favor of Amylyx's ALS drug on second take. But first the co-CEOs had to make a pledge
Second time’s the charm for Amylyx and its experimental ALS drug. In an unusual twist, outside experts on an FDA advisory committee voted 7-2 in favor of approving AMX0035, just months after voting against the drug in a first adcomm.
Even more unusual was a promise from both CDER’s neuroscience director Billy Dunn and Amylyx’s co-CEOs that AMX0035 would be pulled from the market if the drug fails its ongoing Phase III PHOENIX trial.
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