IMCIVREE was first approved by Health Canada in 2023 for weight management in adult and pediatric patients 6 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. Please consult the IMCIVREE product monograph available at www.rhythmtx.ca.

"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."

IMCIVREE, a melanocortin-4 receptor (MC4R) agonist, is the first targeted therapy approved in Canada to treat acquired HO. The Health Canada approval is based on the positive pivotal Phase 3 TRANSCEND trial of setmelanotide in 142 patients with acquired HO. The global study met its primary endpoint, demonstrating a statistically significant 18.8% placebo-adjusted reduction in body mass index (BMI). Results from the Phase 3 TRANSCEND trial were recently published in The New England Journal of Medicine.