SCENESSE® (Afamelanotide) Approved by Health Canada for Erythropoietic Protoporphyria
Key Insights
Health Canada has granted a Notice of Compliance to CLINUVEL's SCENESSE® (search) (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (search) (EPP).
SCENESSE® (search) becomes the only treatment for EPP to receive marketing authorization from any regulatory body worldwide, following prior approvals in Europe (2014), the U.S.A. (2019), and Australia (2020).
The drug has been administered over 21,000 times globally, with the longest-treated patients receiving up to 20 years of continuous therapy, demonstrating a proven long-term safety profile.
Health Canada has granted a Notice of Compliance (NOC) to CLINUVEL PHARMACEUTICALS LIMITED for SCENESSE® (search) (afamelanotide), authorizing the drug for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (search) (EPP). The NOC, announced on July 13, 2026, acknowledges compliance of the SCENESSE® new drug submission with Section C.08.002 and C.08.005 of the Canadian Food and Drug Regulations and grants CLINUVEL the right to market the therapy in Canada.
"Health Canada has taken a long time to arrive at this positive outcome," said Dr Dennis Wright, CLINUVEL's Chief Scientific Officer. "Data from our global programs – including considerable data from postmarketing experience – were used to demonstrate the safety and clinical benefit of SCENESSE® (search) in EPP, where the mechanism of action is well understood. The major benefit of the drug is its proven long-term and consistent safety profile. Other drugs in development for EPP lack these data."
A First-in-Class Systemic Photoprotective Therapy
SCENESSE® (search) is the only treatment for EPP to have received marketing authorisation from any regulatory body worldwide, with the Canadian approval following prior authorizations in Europe (2014), the U.S.A. (2019), and Australia (2020). The drug contains 16 mg of the peptide afamelanotide, an analogue of a naturally occurring hormone that stimulates melanin production in the skin. Through this mechanism, SCENESSE® provides a photoprotective effect by preventing the penetration of light through skin while also acting as a strong antioxidant.
Over 21,000 doses of SCENESSE® (search) have been administered to EPP patients worldwide across clinical trials, compassionate and special access programs, and marketing authorizations. The longest-treated patients have received up to 20 years of continuous therapy under expert care. The drug is administered via subcutaneous implantation in an outpatient setting and is only prescribed and delivered by trained and accredited Specialty Centers in North America and EPP Expert Centres in Europe.
Disease Burden and Patient Access
EPP is a rare metabolic disorder characterized by debilitating phototoxic reactions and burns following brief exposure to visible light, particularly sunlight. The condition is estimated to affect between 5,000 and 10,000 individuals globally, with approximately 1 in 140,000 individuals affected in Canada.
CLINUVEL has already established a network of Specialty Centers across North America following the drug's U.S. FDA approval in 2019. Five Centers in Canada are already trained and accredited, having previously treated EPP patients with SCENESSE® (search) under special access arrangements, positioning the country for a smooth transition to commercial availability.
Safety Profile
SCENESSE® (search) has maintained a positive safety profile for up to two decades in EPP patients. The most commonly reported adverse events in clinical trials included headaches, nausea, implant site reactions, oropharyngeal pain, cough, fatigue, skin hyperpigmentation, dizziness, melanocytic nevus, respiratory tract infection, somnolence, non-acute porphyria, and skin irritation.
Dr Wright expressed gratitude to the CLINUVEL team "for this momentous outcome and their tenacity for ensuring eligible patients may get access to this therapy."