Amylyx Pharmaceuticals submits new drug application for AMX0035 for the treatment of ALS

Amylyx Pharmaceuticals

2 November 2021 - Amylyx Pharmaceuticals today announced it has submitted a new drug application to the U.S. FDA for AMX0035 (sodium phenylbutyrate and taurursodiol) for the treatment of amyotrophic lateral sclerosis.

The submission to the FDA is based on data from the CENTAUR trial, a placebo controlled study evaluating 137 people with amyotrophic lateral sclerosis.

Read Amylyx Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier