Drugs

FDA Extends Review of Amylyx’s ALS Drug

FDA has extended the review of an Amylyx Pharmaceuticals NDA for AMX0035 (sodium phenylbutyrate and taurursodiol) for treating amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. The new user fee review action target date is 9/29.

The agency review extension will allow more time to review additional analyses of data from the company’s clinical studies. The submission of this information was considered a major amendment to the NDA, which resulted in the review extension.

AMX0035 is described as a proprietary oral fixed-dose combination that is designed to reduce the unfolded protein response (UPR), preventing cell death resulting from the UPR and reduced cell death through apoptosis, the company says. It is also intended to target the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases.

FDA Extends Review of Amylyx’s ALS Drug

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