Amylyx Pharmaceuticals, Inc.’s amyotrophic lateral sclerosis drug AMX0035 (sodium phenylbutyrate/taurursodiol) appears on track for US Food and Drug Administration approval following a strongly favorable vote at its second advisory committee review.
Second Time’s The Charm: Amylyx’s ALS Drug Wins US FDA Panel Nod
In switching their votes from the first panel review in March, advisory committee members cited supportive additional analyses of a survival benefit, framing of the issues in the context of unmet need and regulatory flexibility, and the company’s statement that it would withdraw AMX0035 if the Phase III PHOENIX trial does not succeed.
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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