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Imcivree (setmelanotide) – New orphan drug approval

November 27, 2020 - Rhythm Pharmaceuticals announced the FDA approval of Imcivree (setmelanotide), for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

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