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These preclinical insights have been validated in large-scale clinical trials.The FLOW trial (n = 3,533) showed that once-weekly subcutaneous administration of semaglutide (1.0 mg) significantly reduced the risk of a renal composite endpointincluding 50% decline in eGFR, renal failure, or cardiovascular deathby 24% in patients with T2DM and chronic kidney disease (CKD) (HR = 0.76, 95% CI: 0.660.88
doi:10.1080/09513590.2021.1991909 Tinelli A, Panese G, Licchelli M, et al
It is reviewing nominated bulk drug substances for possible inclusion on the 503A Bulks List, with specific reviewed uses and public-comment material
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