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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]

In other words, if the advertiser claims to have a specific level of support (e.g., clinical studies), then the complaint may still challenge the claims as lacking adequate substantiation

The Food and Drug Administration regulates therapeutic peptides separately from research reagents

& Epelbaum, J