This image provided by Amylyx Pharmaceuticals shows the drug Relyvrio. The much-debated drug for Lou Gehrig’s disease won approval by the U.S. Food and Drug Administration on Thursday, Sept. 29, 2022, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines. (Amylyx Pharmaceuticals via AP)
By MATTHEW PERRONE AP Health Writer
WASHINGTON (AP) — U.S. health officials have approved a much-debated drug to treat the deadly illness known as Lou Gehrig’s disease. The approval Thursday follows an intense lobbying campaign by patients and advocates, though it’s also likely to raise questions about the standards used to review experimental medicines. The Food and Drug Administration approved the medication from Amylyx Pharmaceuticals based on results from one small, mid-stage study. The agency’s internal scientists repeatedly said the company’s results were not convincing. But thousands of patients have urged the FDA to be flexible and grant patients’ access. Lou Gehrig’s disease has no cure and most patients die within five years of initial symptoms.