Amylyx (AMLX) Pharmaceuticals announced the launch of a U.S. Expanded Access Program, EAP, for up to 250 adults with post-bariatric hypoglycemia, PBH, to provide treatment access to avexitide, an investigational, first-in-class glucagon-like peptide-1 receptor antagonist. The EAP allows U.S. physicians to request avexitide for adults with PBH following Roux-en-Y gastric bypass surgery who have a serious unmet medical need, are unable to participate in an ongoing clinical trial, have exhausted available management options, and meet all other eligibility criteria. Initial eligible patients include individuals who have completed the pivotal Phase 3 LUCIDITY clinical trial and participants in a prior trial of avexitide in PBH following RYGB surgery.
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