Amylyx said Friday it would discuss its plans for Relyvrio with patients and the FDA, which “may include voluntarily withdrawing” the drug.
The latest company study showed that the drug did not slow the disease compared with a dummy treatment.
Amylyx’s medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable proof that they work.
That commitment seemed to reassure FDA's advisers who voted in favor of the drug's approval, despite the questionable data.
In the months before the decision the FDA faced intense pressure from ALS patients, advocates and members of Congress.
Persons:
Lou Gehrig’s, Amylyx, ”, “, Relyvrio
Organizations:
WASHINGTON, Drug Administration, Amylyx Pharmaceuticals, Relyvrio, FDA, Cambridge, Amylyx Pharmaceuticals Inc, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP
Locations:
U.S