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However, common commentary is intended to highlight issues where FDA and EMA are working toward a more harmonized view (or to provide clarity for sponsors on areas where the agency may be unable to reach alignment)

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In doing so, we advocate for a paradigm that moves beyond traditional indications, embracing the full spectrum of GLP-1R agonists in areas such as primary prevention, microvascular protection, and metabolic liver disease, and metabolic disorders that include cardio-kidney-metabolic (CKM) syndromea systemic disorder characterized by interrelated metabolic, renal, and cardiovascular dysfunction and a broader cardio-renal-metabolic axis that includes central obesity, insulin resistance, dyslipidemia, hypertension, and pre-diabetic states