Rhythm Pharmaceuticals, Inc. (NASDAQ: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that Health Canada has approved IMCIVREE® (setmelanotide) for the additional indication of weight management in adult and pediatric patients four years of age and older with acquired hypothalamic obesity (HO).
IMCIVREE was first approved by Health Canada in 2023 for weight management in adult and pediatric patients six years of age and older with obesity due to Bardet-Biedl syndrome (BBS), or genetically confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency due to variants interpreted as pathogenic, likely pathogenic, or of uncertain significance.
"Acquired hypothalamic obesity is a rare, complex MC4R pathway disease that develops following injury to the hypothalamus, resulting in accelerated and sustained weight gain, hyperphagia and significant impacts on quality of life," said Jennifer Lee, Executive Vice President, Head of North America for Rhythm.
"The approval of this additional indication for IMCIVREE provides healthcare professionals with an important new treatment option for eligible patients in Canada. We are grateful to the Canadian patient and healthcare community and look forward to working to make IMCIVREE available to patients living with acquired hypothalamic obesity."
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