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That's not a technicality - it's a meaningful regulatory distinction that every patient in this category should understand before starting treatment

Wegovy's 2021 approval, Zepbound's 2023 approval, and any future weight-management GLP-1 approval all rely on the same framework that the FDA built around the SCALE program adult population, BMI thresholds, 5% and 10% weight-loss responder definitions, comorbidity sub-analyses

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Wegovy Vision Loss Lawsuit Overview According to legal documents, patients allege that Novo Nordisk, the manufacturer of Wegovy, knew the drug might increase a persons risk of developing serious eye injuries such as nonarteritic anterior ischemic optic neuropathy (NAION) and failed to adequately warn consumers

doi: 10.1038/mp.2017.187 [DOI] [PMC free article] [PubMed] [Google Scholar] Lu J, Zou S, Liu X, Wong TYP, Zhang X, Xu KS, Zhao Y, Hong Y, Cen A, Wang Y