When the US Food and Drug Administration approved Amylyx Pharmaceuticals, Inc.’s amyotrophic lateral sclerosis drug Relyvrio, the agency exercised its regulatory flexibility in concluding there was substantial evidence of effectiveness.
Amylyx’s Relyvrio: US FDA Review Shows Regulatory Flexibility Can Come In Many Forms
Pink Sheet Drug Review Profile looks at how the agency determined that Amylyx’s ‘conceptual basis’ for use of the drug’s two active ingredients to treat ALS was enough to satisfy the combination drug rule; the sponsor also was allowed to submit certain animal studies and drug-drug interaction data during the course of the NDA review.
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