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Amylyx’s Relyvrio Could See Fast Sales Growth, But Also Spark Pricing Debate

Interpret Survival Analysis “Cautiously,” Label Advises

 
• By Alaric DeArment

The FDA gave full approval based on a Phase II study, without the need for Phase III confirmatory data, for Amylyx’s ALS drug Relyvrio but the $158,000 WAC could spark a debate over pricing.

The FDA approved Amylyx's Relyvrio for amyotrophic lateral sclerosis • Source: Shutterstock

Amylyx Pharmaceuticals, Inc.’s Relyvrio (sodium phenylbutyrate and taurursodiol) marks a milestone as the first new US Food and Drug Administration approval of a drug for amyotrophic lateral sclerosis (ALS) in five years, but it could spark a debate over cost and cost-effectiveness due to its six-figure price tag and lingering uncertainty around its efficacy.

The FDA approved Relyvrio on 29 September with a broad label for ALS in adults, based on data from the Phase II CENTAUR study that showed efficacy on the primary endpoint of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) as well as a confirmatory survival benefit in a long-term follow-up

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