ALS network seeks chance for new drug

Less than a year after the controversial approval of the Alzheimer’s drug Aduhelm, the Food and Drug Administration may soon approve another drug for a deadly neurodegenerative disease based on partial data. The FDA meets this week to review evidence from a small, mid-stage study of Amylyx Pharmaceuticals’ drug for ALS, or amyotrophic lateral sclerosis.

Regulators told Amylyx last year it would need to conduct a large, confirmatory study before seeking approval. But after months of intense lobbying by ALS patients and their representatives in Congress, the agency said it could submit the drug based on the smaller study. The change was so abrupt it surprised even some doctors who helped study the treatment, which appears to modestly slow patients’ decline.

ALS, also known as Lou Gehrig’s disease, destroys nerve cells needed to walk, talk, swallow and – eventually – breathe. There is no cure and most people die within three to five years.

KEVIN ALLEN The ALS Association via AP ALS Association members meet this month on Capitol Hill while lobbying officials for access to an experimental drug.