FDA-approved ALS drug Relyvrio fails trial, faces removal from market

One of the few drugs available to treat amyotrophic lateral sclerosis, or ALS, may be taken off the market after failing in a large clinical trial nearly two years after its controversial approval by the Food and Drug Administration.

Researchers in the Phase 3 trial found "no significant difference" in patients taking the drug, called Relyvrio, compared to patients taking a placebo, according to a statement released Friday by the drug's maker Amylyx Pharmaceuticals.

In the 48-week trial, the Cambridge, Massachusetts-based company enrolled 664 adults living with ALS. The disease, also commonly known as Lou Gehrig's disease, gradually destroys nerve connections necessary for basic movements and, eventually, breathing. There is no cure and most people die within three to five years after diagnosis.

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