Early PHOENIX Data Would Not Have Aided Approval Decision On Amylyx’s Relyvrio – US FDA
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.
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Amylyx's Relyvrio: The Road To Regulatory Flexibility And US FDA Approval
A Pink Sheet timeline shows the regulatory highs and lows of AMX0035's path to US approval for treatment of amyotrophic lateral sclerosis.
How Will Approval Of Amylyx’s Relyvrio Impact The Ongoing PHOENIX Trial?
Launched in part to help resurrect AMX0035’s regulatory prospects, the multiregional PHOENIX study is winding down in the US. There still may be some risk of potential dropouts, however.
Amylyx’s ALS Pledge Vs. FDA’s Obscure Withdrawal Authority: Which Holds More Power?
Office of Neuroscience Director Billy Dunn touted FDA’s ability to withdraw approval for AMX0035 if subsequent data indicate a lack of substantial evidence of effectiveness. However, this provision appears to have been infrequently used and involves a potentially time-consuming hearing.