- Health Canada granted a Notice of Compliance (NOC) to CLINUVEL’s Scenesse (afamelanotide) for preventing phototoxicity in adults with erythropoietic protoporphyria (EPP).
- Scenesse is the only approved therapy for EPP globally and has demonstrated a long-term safety profile, with more than 21,000 doses administered worldwide.
- The approval adds Canada to existing authorizations in Europe, the US, and Australia, while five accredited Canadian specialty centers have already treated patients through special access programs.
- The peptide therapy stimulates melanin production to provide photoprotection, offering a new treatment option for Canadians living with this rare light-sensitive disorder.
Takeaways
The Canadian NOC formally moves Scenesse from special‑access cases to on‑label, publicly or privately reimbursed treatment for erythropoietic protoporphyria, eliminating administrative friction for patients and enabling Canadian specialty centers to prescribe it under routine drug plan processes rather than ad‑hoc access.
Source: Globenewswire
