Amylyx’s ALS therapy secures FDA approval, as regulatory flexibility trumps underwhelming data

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Amylyx’s ALS therapy secures FDA approval, as regulatory flexibility trumps underwhelming data

Amylyx’s ALS therapy secures FDA approval, as regulatory flexibility trumps underwhelming data

3 de novembro de 2022 posted by CIEnP Category:

The FDA granted full approval to Amylyx’s AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS), a severe neurological disorder that causes paralysis and death. The agency convened its independent experts twice to discuss the therapy’s mixed and complex data package. AMX0035 is the third drug to secure FDA approval for ALS, following now-generic riluzole in 1995 and Mitsubishi Tanabe’s edaravone in 2017…

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Fonte 786 | november 2022 | volume 21 news in brief www.nature.com/nrd