Pressured by patients, FDA reviews ALS drug with modest data

By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) — The Food and Drug Administration meets next week to review a closely watched drug for ALS, or Lou Gehrig’s disease, following months of lobbying by patient groups and congressional lawmakers. The drug from Amylyx Pharmaceuticals showed modest benefits in one small study and the FDA told the company last April to run a larger one before seeking approval. But that delay sparked pushback from patients, their families and members of Congress. In September the FDA reversed course and agreed to review the drug based on the single study. Experts say it’s the latest example of patients exerting political pressure to push drugs through the FDA approval process.