CLINUVEL (ASX:CUV) has announced that Health Canada has granted a Notice of Compliance allowing SCENESSE to be marketed in the country for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP), a rare metabolic disorder that causes debilitating phototoxic reactions and burns after brief exposure to visible light.
Dr Dennis Wright, CLINUVEL’s Chief Scientific Officer, said, “Health Canada has taken a long time to arrive at this positive outcome.”
“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 contains the peptide afamelanotide, an analogue of a naturally occurring hormone that stimulates melanin production and provides photoprotection while acting as a strong antioxidant.
The medicine is the first systemic photoprotective drug approved for EPP and had previously received marketing authorisation in Europe in 2014, the United States in 2019, and Australia in 2020.
CLINUVEL said that over 21,000 doses of SCENESSE have been administered to EPP patients worldwide and that some patients have received continuous therapy for up to 20 years under expert care.
To support Canadian treatment, CLINUVEL has established a network of specialty centres across North America. Five of these centres are already trained and accredited in Canada and have treated EPP patients with SCENESSE under special access arrangements.
EPP is estimated to affect between 5,000 and 10,000 people globally and approximately 1 in 140,000 individuals in Canada, creating a pressing need for safe and effective options for those who experience severe light-induced reactions.
