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Mechanisms Mediating the Diuretic and Natriuretic Actions of the Incretin Hormone Glucagon-Like Peptide-1
Rhythm Pharmaceuticals, the developer of setmelanotide, has successfully pursued regulatory approval for the drug (marketed as IMCIVREE) in conditions caused by upstream defects in the MC4R pathway, such as POMC and LEPR deficiencies, where the receptor itself is intact, and the agonist mechanism is highly effective [57]
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Bankir, L., Roussel, R
NDA submission The NDA package will include all preclinical data, Phase 1, 2, and 3 trial results, manufacturing information, proposed labeling, and risk management plans
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