Rhythm Pharma gets positive CHMP opinion to expand IMCIVREE label for acquired hypothalamic obesity

RHYTHM PHARMACEUTICALS, INC.

CHMP recommends expanding IMCIVREE (setmelanotide) marketing authorization to treat obesity/control hunger in patients >=4 years with acquired HO due to hypothalamic injury.
European Commission decision on label expansion anticipated in Q2 2026.
Follows FDA approval last week; CEO cites broad label and global drug development approach.
Acquired HO is a rare neuroendocrine disease with impaired MC4R pathway signaling causing rapid weight gain and hyperphagia.

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