September 30, 2022
Life Sciences
  • The FDA approved Amylyx Pharmaceuticals Inc.’s ALS drug Relyvrio, the first treatment for Lou Gehrig’s disease that the agency has cleared in five years. Patient advocacy groups had pressured the FDA to approve the new treatment, though there’s still some uncertainty about the drug’s efficacy: Amylyx’s submission for approval is based on data from a small Phase 2 trial, and the FDA’s own advisory committee initially voted this spring that the data didn’t show that the drug was effective, before changing its opinion this month. (Articles here, here, here, and here)