The FDA meets next week to publicly review evidence from a small, mid-stage study of AMX0035, a drug made by Amylyx Pharmaceuticals, which shows modest effects on patients’ decline.
Mar. 25, 2022 -- The FDA is reviewing evidence for a drug that could help ALS, or amyotrophic lateral sclerosis.
Patients and advocates have pushed for approval of a drug to treat the neurodegenerative disease, also known as Lou Gehrig’s disease. ALS damages nerve cells and leads to a decline in the ability to walk, talk, swallow and breathe. There is no cure, and most people die in 3-5 years. Last year, federal regulators said Amylyx would need to conduct a large trial before seeking approval. However, after months of lobbying by patients and advocates, the FDA said the company could submit an application based on the smaller study.
“This is what many people were concerned about in terms of the precedent for FDA approving Aduhelm,” Joseph Ross, MD, a professor of medicine and public health at Yale University, told the AP.