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Early PHOENIX Data Would Not Have Aided Approval Decision On Amylyx’s Relyvrio – US FDA

 
• By Sue Sutter

Agency considered Amylyx’s plan to submit unblinded efficacy data from the ongoing Phase III trial during the ALS drug's NDA review but ultimately decided against it, citing concerns about study integrity and the small amount of data likely to be available.

Drug Review Profile: Relyvrio
FDA decided not to look at early data from an ongoing Phase III study before approving Relyvrio. • Source: Shutterstock

The US Food and Drug Administration considered Amylyx Pharmaceuticals, Inc.’s plan to submit unblinded data from an ongoing Phase III trial during the review of the amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate/taurursodiol) but ultimately decided against this, citing the risk to study integrity and the small amount of data likely to be available.

Prior to and during the course of the new drug application review for Relyvrio (previously known as AMX0035), there was discussion regarding whether early unblinded data from the PHOENIX

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