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# Amylyx to File NDA Based on Positive Phase 3 Results for Avexitide
- URL: https://www.fdaweb.com/amylyx-to-file-nda-based-on-positive-phase-3-results-for-avexitide/
- Published: 2026-08-18T12:00:00.000Z
- Updated: 2026-09-14T13:45:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161645

Amylyx Pharmaceuticals says it will file an NDA by the end of the year for its investigational drug avexitide after new data show significantly reduced hypoglycemic events in a Phase 3 clinical trial involving patients with post-bariatric hypoglycemia (PBH).The company just reported topline results from the 78-participant LUCIDITY trial evaluating avexitide in adults who developed PBH following Roux-en-Y gastric bypass surgery.

The trial met its FDA-agreed primary endpoint, with avexitide producing a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared with placebo through Week 16\. LUCIDITY also met all secondary endpoints, demonstrating statistically significant reductions in Level 2 hypoglycemic events measured through self-monitoring of blood glucose and continuous glucose monitoring, as well as Level 3 hypoglycemic events independently adjudicated by investigators.

PBH is described as a chronic metabolic complication that can occur after bariatric surgery and is characterized by recurrent episodes of low blood glucose, often occurring after meals. Severe hypoglycemia can result in cognitive impairment, loss of consciousness, seizures and the need for assistance from another person.