Amylyx scores FDA approval for ALS drug

Sept. 30, 2022

After a bumpy road, Amylyx finally scored FDA approval for its amyotrophic lateral sclerosis (ALS) AMX0035, now branded as Relyvrio.

Just a few weeks ago, the company announced that an FDA Advisory Committee had met for the second time and reversed its opinion, choosing to recommend the approval for the drug candidate.

Relyvrio is an oral fixed-dose combination of sodium phenylbutyrate and taurursodiol, and it’s designed to preserve neurons by blocking cell death pathways in the mitochondria and endoplasmic reticulum. The drug is now approved to be taken on its own or in combination with other therapies. 

In trials, Relyvrio showed promise in helping to slow the loss of physical function in people living with ALS, which Amylyx says represents an important milestone in treatment for the neurodegenerative disorder.  In the recent announcement, Amylyx also said that it would be pricing the drug “below the latest FDA-approved product available to people with ALS.”