CLINUVEL seeks Canadian drug approval

CLINUVEL Pharmaceuticals (ASX:CUV) has announced that Health Canada has validated and accepted the New Drug Submission for SCENESSE® for review. This marks a significant step towards offering treatment for erythropoietic protoporphyria (EPP) patients in Canada. The decision is anticipated by Q4 2025.

Overview and future outlook for SCENESSE® in Canada

CLINUVEL Pharmaceuticals has taken a key step in providing treatment for EPP patients in Canada with the validation of SCENESSE® by Health Canada. Currently, there is no approved treatment for EPP in Canada, but patients have had access to SCENESSE® through a Special Access Program since 2023. With a formal marketing authorization expected by Q4 2025, CLINUVEL aims to extend access to approximately 280 Canadian EPP patients. Supported by a network of Specialty Centers and previous international approvals, CLINUVEL is well-prepared to address Health Canada's review process. The company remains focused on mitigating potential risks and expanding SCENESSE® availability globally.

Executive insights on SCENESSE® submission

The filing of SCENESSE® with Health Canada is a significant milestone for CLINUVEL as we continue to expand the availability of the first treatment for EPP patients globally. We have successfully launched SCENESSE® in other major markets and are committed to working closely with Health Canada to bring this treatment to Canadian patients.