Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that Health Canada has approved Imcivree (setmelanotide) for weight management in adult and pediatric patients four years of age and older with acquired hypothalamic obesity (HO).

The approval adds an indication to Imcivree, which Health Canada first cleared in 2023 for weight management in patients six years and older with obesity due to Bardet-Biedl syndrome or certain genetically confirmed deficiencies.

The approval is based on the Phase 3 TRANSCEND trial involving 142 patients with acquired HO. The trial met its primary endpoint, showing an 18.8% placebo-adjusted reduction in body mass index. Results from the trial were published in The New England Journal of Medicine.

Imcivree is a melanocortin-4 receptor (MC4R) agonist. Acquired HO is characterized by accelerated and sustained weight gain following injury to the hypothalamus, which most frequently occurs after the growth or treatment of craniopharyngioma, astrocytoma, or other hypothalamic-pituitary tumors.

Jill Hamilton, M.D., a paediatric endocrinologist at The Hospital for Sick Children, commented on the approval, noting that treatment options for patients with acquired hypothalamic obesity have been limited. Dr. Hamilton has received institutional support for industry-sponsored studies, including setmelanotide trials from Rhythm Pharmaceuticals.

Imcivree holds approval from the U.S. Food and Drug Administration for acquired HO in patients four years and older, and has also been authorized by the European Commission and the UK's Medicines and Healthcare Products Regulatory Agency for the same indication.