Amylyx Pharmaceuticals Launches U.S. Expanded Access Program for Post-Bariatric Hypoglycemia Patients
Amylyx Pharmaceuticals has announced the initiation of a U.S. Expanded Access Program (EAP) for adults suffering from post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery. This program provides access to avexitide, an investigational glucagon-like peptide-1 receptor antagonist, for up to 250 eligible patients. The EAP is designed for individuals with serious unmet medical needs who cannot participate in ongoing clinical trials and have exhausted other management options. Avexitide is currently being evaluated in the Phase 3 LUCIDITY clinical trial, with results expected in the third quarter of 2026. The trial aims to assess the efficacy and safety of avexitide in reducing hypoglycemic events in PBH patients.