ALS drug will be pulled from U.S. market after study showed patients didn’t benefit

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The drugmaker announced that its drug had failed to show any benefit for patients in a 600-person study.

WASHINGTON — The maker of a drug for Lou Gehrig’s disease that recently failed in a large study said Thursday it will pull the medicine from the market, acknowledging it didn’t help patients with the deadly neurological condition.

The Food and Drug Administration approved the much-debated drug, Relyvrio, in September 2022, following a years-long advocacy campaign by patients with amyotrophic lateral sclerosis, or ALS. Cambridge, Massachusetts-based Amylyx also said Thursday it will lay off 70% of its more than 350 employees as part of a major restructuring effort. Company executives said they plan to continue studying Relyvrio and another experimental drug for several rare diseases, including Wolfram syndrome, which causes childhood diabetes and blindness.

The medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable evidence they work.

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