Amylyx Archives

FDA approves first ALS drug in 5 years after pleas from patients

Washington Post, September 29, 2022: FDA approves new ALS drug for Lou Gehrig’s disease despite NCHR and other experts’ criticisms that the drug’s effectiveness is questionable and FDA evidence standards should be higher.

FDA advisers to discuss ALS drug at Wednesday meeting

Politico, March 29, 2022. On March 30, FDA holds a highly anticipated advisory committee on neurological drugs to discuss a drug from Amylyx that aims to treat amyotrophic lateral sclerosis (ALS). Dr. Diana Zuckerman told Politico: “Did the FDA schedule an advisory committee meeting to placate patient advocates and other political pressure in the hope that the advisory committee would vote against it? Or is the FDA really considering approving it?”