8 minute read
Jan. 15, 2024

A Bear Bile Acid in a Controversial ALS Approval: Taurursodiol + Phenylbutyrate

drughunter.com
Drug Hunter Team

Relyvrio, developed by Amylyx Pharmaceuticals, is a combination treatment of 3 g sodium phenylbutyrate and 1 g taurursodiol, which was approved by the FDA in Sep. 2022 for amyotrophic lateral sclerosis (ALS) (“Lou Gehrig’s disease”) in adults. The approval was controversial, with an Advisory Committee initially voting against approval based on Ph. II data. Is the drug a success story for phenotypic drug discovery, or is it a misallocation of society’s resources? This article reviews what happened and why there’s not an easy answer.

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