ARTICLE | Regulation
Amylyx ALS therapy on deck at FDA
After more data, a year of talks with FDA and patient pressure, an NDA for AMX0035 is under review while Amylyx readies for Phase III
November 3, 2021 1:07 AM UTC
A year ago, Amylyx believed it would have to complete an additional trial before seeking approval of AMX0035; now, the company has the next best chance to get an ALS therapy across the goal line at FDA.
On Tuesday Amylyx Pharmaceuticals Inc. announced it submitted an NDA for AMX0035 to treat amyotrophic lateral sclerosis, capping a year of discussions with FDA about the path forward for the therapy...