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Setmelanotide approval for rare genetic variants and future directions Setmelanotide was approved in 2020 for use in children aged 6 years or older who have POMC, PCSK1, or LEPR deficiency in whom genetic testing has confirmed variants in POMC , PCSK1 , or LEPR genes that are considered to be pathogenic, those likely to be pathogenic, or those of uncertain significance