Health Canada NOC enables treatment for porphyria, metabolic disorder
MELBOURNE, Australia, July 13, 2026 (GLOBE NEWSWIRE) -- CLINUVEL's novel drug SCENESSE® (afamelanotide) has been granted a Notice of Compliance (NOC) by Health Canada for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
The NOC acknowledges the 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 SCENESSE® in Canada.
Commentary
"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® 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.
"I thank our team for this momentous outcome and their tenacity for ensuring eligible patients may get access to this therapy," Dr Wright said.
SCENESSE® for EPP: peptide therapy with demonstrated long-term safety profile
SCENESSE® is the only treatment for EPP to have received marketing authorisation – recognising the drug's clinical benefit, safety and quality – from any regulatory body worldwide. The Canadian approval follows marketing authorisations in Europe (2014), the U.S.A. (2019) and Australia (2020).
CLINUVEL has built a network of Specialty Centers across North America to treat EPP patients following the drug's 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® under special access arrangements.
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.
SCENESSE® 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® have been administered to EPP patients worldwide, with the longest treated patients receiving up to 20 years of continuous therapy under expert care.