U.S. regulators approved Amylyx Pharmaceuticals’ Relyvrio in 2022, following a years-long advocacy campaign by patients and their families.
WASHINGTON — The maker of a much-debated drug for Lou Gehrig’s disease said Friday its therapy failed to help patients in a large follow-up study, but stopped short of committing to follow through on a prior pledge to pull the drug from the U.S. market.
Amylyx said Friday it would discuss its plans for Relyvrio with patients and the FDA, which “may include voluntarily withdrawing” the drug. Executives said in a statement they were “surprised and disappointed” by the results and hoped to announce their plans in the next two months.
The latest company study showed that the drug did not slow the disease compared with a dummy treatment. The drug also failed to show improvement on any secondary measures, such as muscle strength.
Amylyx’s medication is part of a string of drugs for deadly, degenerativediseases that have won …