- Health Canada approved Imcivree (setmelanotide) for weight management in adults and children 4 years and older with acquired hypothalamic obesity (HO).
- Imcivree is the first targeted therapy approved in Canada for acquired HO, a rare condition caused by hypothalamic injury that can lead to sustained weight gain and hyperphagia.
- Approval was supported by the Phase 3 TRANSCEND trial in 142 patients, which showed an 18.8% placebo-adjusted reduction in BMI.
- Imcivree was previously approved in Canada for patients 6 years and older with obesity associated with Bardet-Biedl syndrome and certain genetic deficiencies.
Takeaways:
Health Canada’s approval of Imcivree (setmelanotide) for acquired hypothalamic obesity (HO) gives Rhythm Pharmaceuticals its first targeted therapy in Canada for this rare, injury‑driven form of obesity, extending the drug’s existing Canadian indications for genetic obesity (Bardet‑Biedl syndrome and POMC/PCSK1/LEPR deficiencies). Backed by the Phase 3 TRANSCEND trial showing an 18.8% placebo‑adjusted BMI reduction in 142 patients, the new indication (adults and children ≥4 years) broadens the treatable population beyond purely genetic cases and strengthens Rhythm’s rare‑obesity franchise in Canada as it works with payers and centres to enable access for eligible patients.
Source: Globenewswire
