Rhythm Pharmaceuticals, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization for IMCIVREE®? (setmelanotide) include children between 2 and younger than 6 years old with obesity due to Bardet Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. IMCIVREE is the first-ever authorized treatment option in the European Union for control of hunger and treatment of obesity and in adults and children 6 years of age and above living with BBS or POMC, PCSK1, or LEPR deficiency.

The CHMP opinion on the marketing authorization to include patients as young as 2 years old now will be reviewed by the European Commission (EC), which has the authority to grant marketing authorizations for medicinal products in the European Union (EU). A final decision on the application to expand the marketing authorization for setmelanotide is anticipated in the second half of 2024.