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Regulatory Flexibility: US FDA Approves Amylyx’s Relyvrio For ALS Despite ‘Degree Of Residual Uncertainty’

 
• By Sue Sutter

The single positive Phase II CENTAUR study, along with confirmatory evidence of benefit on long-term survival in the open-label extension, demonstrate substantial evidence of effectiveness, the agency says, acknowledging a level of uncertainty that is acceptable in the disease context.

Muscles and neurons
FDA approved Amylyx's AMX0035 for treatment of ALS. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

In approving Amylyx Pharmaceuticals, Inc.’s Relyvrio (formerly AMX0035) for amyotrophic lateral sclerosis on 29 September, the US Food and Drug Administration decided it did not first need to see the results of the ongoing Phase III PHOENIX trial.

Rather, the agency concluded the single positive Phase II CENTAUR study, along with confirmatory evidence from the observed benefit on long-term survival in the study’s open-label extension, collectively demonstrate

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