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This represents a boundary case where regulatory flexibility, combined with restricted labeling, enabled approval despite pharmacokinetic constraints that would preclude approval for most indications (Melmed et al., 2015)

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Exendin-4 differs from human GLP-1 by about 50% of its amino acids, importantly having a glycine instead of alanine at the N-terminus (making it DPP-4 resistant) ( [46] )