Health Canada Pushes SCENESSE® Review into 2026, Impacting Canadian Patients
Health Canada has requested additional information, extending its review of CLINUVEL’s SCENESSE® for erythropoietic protoporphyria (EPP) into 2026. Meanwhile, Canadian patients continue to access the treatment via a Special Access Program.
- Health Canada delays SCENESSE® approval, review extended into 2026
- Additional information requested despite prior approvals in US, Europe, Australia
- SCENESSE® remains accessible in Canada through Special Access Program
- Treatment targets rare metabolic disorder erythropoietic protoporphyria (EPP)
- CLINUVEL expresses disappointment but commits to robust regulatory response
Regulatory Setback in Canada
CLINUVEL Pharmaceuticals has announced that Health Canada has requested more time and additional information to complete its evaluation of SCENESSE® (afamelanotide) for the treatment of erythropoietic protoporphyria (EPP), a rare and debilitating metabolic disorder. Originally accepted for review in December 2024, the regulatory process is now expected to extend into 2026, delaying formal approval in the Canadian market.
Health Canada’s request comes as a surprise to CLINUVEL, whose SCENESSE® has already secured marketing authorisations in multiple major jurisdictions including the United States, Europe, Australia, and Israel. The company’s Chief Scientific Officer, Dr Dennis Wright, expressed disappointment but reaffirmed CLINUVEL’s commitment to providing thorough responses to the regulator’s inquiries.
Patient Access Maintained Amid Delay
Despite the regulatory delay, Canadian patients diagnosed with EPP continue to receive SCENESSE® through the Special Access Program, ensuring ongoing treatment availability. This program allows patients to access unapproved therapies under medical supervision, mitigating immediate impacts on patient care while the formal approval process unfolds.
SCENESSE® is notable as the only approved systemic photoprotective treatment for EPP, a condition characterized by extreme sensitivity to sunlight that can cause severe phototoxic reactions. The injectable implant is administered bi-monthly and works by releasing afamelanotide in controlled doses to protect skin cells without affecting the central nervous system.
Implications for CLINUVEL and the Market
The extension of Health Canada’s review introduces uncertainty around the timing of SCENESSE®’s commercial launch in Canada, a market currently without an approved treatment for EPP. While the delay may temper near-term revenue expectations, CLINUVEL’s established approvals elsewhere and ongoing patient access programs provide some reassurance.
Investors and analysts will be watching closely for CLINUVEL’s forthcoming responses to Health Canada’s requests and any updates on the regulatory timeline. The situation also highlights the variability in regulatory environments across regions, even for therapies with established safety and efficacy profiles.
Looking ahead, CLINUVEL’s ability to navigate this extended review successfully will be critical to unlocking the Canadian market potential and reinforcing its global leadership in photomedicine for rare disorders.
Bottom Line?
The extended review delays Canadian approval but keeps patient access alive, setting the stage for a pivotal regulatory showdown in 2026.
Questions in the middle?
- What specific additional information has Health Canada requested from CLINUVEL?
- How might the delay affect CLINUVEL’s Canadian market entry and revenue forecasts?
- Could this regulatory extension signal broader challenges for SCENESSE® approvals in other jurisdictions?
