Health Canada clears IMCIVREE for acquired hypothalamic obesity
Health Canada cleared Rhythm Pharmaceuticals’ IMCIVREE (setmelanotide) for weight management in acquired hypothalamic obesity patients aged 4 and older.
Label expansion follows the Phase 3 TRANSCEND trial in 142 patients, showing an 18.8% placebo-adjusted BMI reduction.
IMCIVREE becomes the first targeted therapy authorized in Canada for acquired hypothalamic obesity.