Despite questionnble data, FDA approves ALS drug.
The FDA later requested additional information from Amylyx, delayed its final ruling on the new drug application to today, and called for a second review meeting — a virtually unheard-of move.at a different outcome. In that report, regulators said new data from Amylyx were not"sufficiently independent or persuasive" to establish effectiveness.
Today, panelists heard additional data that Amylyx claims confirms the results of the CENTAUR study, including new analyses of the previously submitted survival data and new data from that study and an open-label extension.
However, results aren't expected until late 2023 or early 2024, which"places the agency in a challenging situation of potentially making a regulatory decision that may not be subsequently confirmed by the results of the ongoing study." If the FDA were to approve AMX0035 and results from the PHOENIX trial ultimately fail to prove efficacy, Justin Klee, co-CEO, and co-founder of Amylyx Pharmaceuticals, said the company would withdraw the drug.
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Biomarker data prove critical for ALS drug evaluation at FDABiomarker data prove critical for ALS drug evaluation at FDA, with a vote recommending approval of AmylyxPharma AMX0035. Our latest column in The Clinical Pipeline, from CyrilPedia
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