Clinuvel’s SCENESSE® Drug Application Validated by Health Canada

Clinuvel Pharmaceuticals Limited (AU:CUV) has released an update.

Clinuvel Pharmaceuticals Limited has received validation from Health Canada for its New Drug Submission of SCENESSE®, a photoprotective therapy for patients with erythropoietic protoporphyria (EPP). The decision on Canadian marketing authorization is anticipated by Q4 2025, potentially expanding treatment access to the estimated 280 EPP patients in Canada. Clinuvel’s established network of Specialty Centers across North America supports its efforts to facilitate wider access to this novel therapy.

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