Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS

Amylyx Pharmaceuticals

4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine (also known as taurursodiol)) for the treatment of amyotrophic lateral sclerosis.

The submission to the EMA is based on data from the CENTAUR trial, a randomized, double-blind, placebo-controlled Phase 2 clinical trial conducted at 25 centers of the Northeast ALS Consortium, evaluating 137 adults with amyotrophic lateral sclerosis.

Read Amylyx Pharmaceuticals press release

Michael Wonder

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Michael Wonder