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# FDA Accepts Amylyx’ Alzheimer Drug NDA
- URL: https://www.fdaweb.com/fda-accepts-amylyx-alzheimer-drug-nda/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150809

FDA has accepted an Amylyx Pharmaceuticals NDA for its AMX0035, an experimental therapy to address pathways leading to neuronal cell death in Alzheimer’s patients. The agency set a 6/26 PDUFA target date to act on the NDA, [reports](https://medcitynews.com/2021/12/fda-sets-decision-date-for-amylyx-pharma-als-drug-that-improves-neuron-survival/?ref=fdaweb.com) *MedCity News.*

The agency granted the NDA priority review and plans to schedule an advisory committee meeting to discuss its safety and efficacy, the report says.

The submission is based on results from a Phase 2 trial that met its main endpoint of slowing disease progression. While FDA initially said Amylyx needed to conduct a Phase 3 trial before seeking regulatory approval, company discussions with the agency led to filing the NDA based on the Phase 2 study results, *MedCity News* says. A Phase 3 trial is now underway and expects to enroll 600 patients.