MELBOURNE, Australia, July 13, 2026 (GLOBE NEWSWIRE) — CLINUVEL\u2019s novel drug SCENESSE\u00ae (afamelanotide) has been granted a Notice of Compliance (NOC) by Health Canada for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).<\/p>\n
The NOC acknowledges the compliance of the SCENESSE\u00ae 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 SCENESSE\u00ae in Canada.<\/p>\n
Commentary<\/strong><\/p>\n \u201cHealth Canada has taken a long time to arrive at this positive outcome,\u201d said Dr Dennis Wright, CLINUVEL\u2019s Chief Scientific Officer. \u201cData from our global programs \u2013 including considerable data from postmarketing experience \u2013 were used to demonstrate the safety and clinical benefit of SCENESSE\u00ae 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.<\/p>\n \u201cI thank our team for this momentous outcome and their tenacity for ensuring eligible patients may get access to this therapy,\u201d Dr Wright said.<\/p>\n SCENESSE\u00ae for EPP: peptide therapy with demonstrated long-term safety profile<\/strong><\/p>\n SCENESSE\u00ae is the only treatment for EPP to have received marketing authorisation \u2013 recognising the drug\u2019s clinical benefit, safety and quality \u2013 from any regulatory body worldwide. The Canadian approval follows marketing authorisations in Europe (2014), the U.S.A. (2019) and Australia (2020).<\/p>\n CLINUVEL has built a network of Specialty Centers across North America to treat EPP patients following the drug\u2019s approval by the U.S. Food and Drug Administration in 2019. Five Centers are already trained and accredited in Canada and have treated EPP patients with SCENESSE\u00ae under special access arrangements.<\/p>\n EPP is a rare metabolic disorder which causes debilitating phototoxic reactions and burns following brief exposure to visible light, particularly sunlight. It is estimated to affect 5,000-10,000 individuals globally, including approximately 1 in 140,000 individuals in Canada.<\/p>\n SCENESSE\u00ae contains 16mg of the peptide afamelanotide, an analogue of a naturally occurring hormone which stimulates the production of melanin in skin. The drug provides a photoprotective effect, preventing the penetration of light through skin as well as acting as a strong antioxidant. Over 21,000 doses of SCENESSE\u00ae have been administered to EPP patients worldwide, with the longest treated patients receiving up to 20 years of continuous therapy under expert care.<\/p>\n About SCENESSE\u00ae (afamelanotide)<\/strong><\/p>\n SCENESSE\u00ae (afamelanotide), is approved for commercial distribution in Europe, the U.S.A., Canada, and Australia as the world\u2019s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). The drug has been administered over 21,000 times to EPP patients across clinical trials, compassionate and special access programs, and marketing authorizations. SCENESSE\u00ae is only prescribed and administered by trained and accredited Specialty Centers (North America) and EPP Expert Centres (Europe), with the subcutaneous implantation occurring in an outpatient setting.<\/p>\n SCENESSE\u00ae has maintained a positive safety profile for up to two decades in EPP patients. Most commonly reported adverse events in clinical trials were headaches, nausea, implant site reactions, oropharyngeal pain, cough, fatigue, skin hyperpigmentation, dizziness, melanocytic nevus, respiratory tract infection, somnolence, non-acute porphyria and skin irritation. For more information, please see https:\/\/www.clinuvel.com<\/a>.<\/p>\n About CLINUVEL PHARMACEUTICALS LIMITED<\/strong><\/p>\n CLINUVEL (ASX: CUV; ADR LEVEL I: CLVLY; B\u00f6rse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL\u2019s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives.<\/p>\n Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the U.S.A. For more information, please go to\u00a0https:\/\/www.clinuvel.com<\/a>.<\/p>\n
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