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.
Amylyx’s Relyvrio Could See Fast Sales Growth, But Also Spark Pricing Debate
Interpret Survival Analysis “Cautiously,” Label Advises
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.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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