The FDA Is Rushing a New and Unproven ALS Drug

The FDA’s decision may have far-reaching effects, something that was clear from the very start of yesterday’s unusual meeting. During his opening remarks, Billy Dunn, director of FDA’s office of neuroscience, stressed to the advisors that the agency has the power to remove a drug if a larger trial did not prove its effectiveness. He then called on Amylyx to voluntarily withdraw the study if a Phase 3 study, dubbed “PHOENIX,” failed. Results from that ongoing study are due by early 2024.