Rhythm Pharmaceuticals receives positive CHMP opinion for IMCIVREE

Rhythm Pharmaceuticals 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 include children between 2 and younger than 6 years old with obesity due to Bardet Biedl syndrome or pro-opiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor 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, which has the authority to grant marketing authorizations for medicinal products in the European Union. A final decision on the application to expand the marketing authorization for setmelanotide is anticipated in the second half of 2024.