AGG Food & Drug team leader Alan Minsk was quoted in a Pink Sheet article titled, “Amylyx’s Relyvrio: US FDA Review Shows Regulatory Flexibility Can Come In Many Forms,” published on November 9, 2022.
The article discussed how FDA determined that Amylyx’s “conceptual basis” for use of the drug Relyvrio’s two active ingredients — sodium phenylbutyrate and taurursodial — to treat ALS was enough to satisfy the combination drug rule. Additionally, the sponsor was allowed to submit certain animal studies and drug-drug interaction data during the course of the NDA review. The review documents highlight that FDA’s regulatory flexibility can come in many forms that will help speed the road to market for a drug intended to treat a serious disease with a high unmet need.
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