Clinuvel Pharmaceuticals seeks Health Canada approval for SCENESSE

Clinuvel Pharmaceuticals (ASX:CUV) has submitted a new drug submission to Health Canada for SCENESSE (afamelanotide).

The drug is aimed at preventing phototoxicity in adults with erythropoietic protoporphyria.

If approved, this would mark the first available treatment for Canadian EPP patients.

Health Canada's Health Products and Food Branch will review the submission, evaluating its safety, efficacy, and quality.

The review process is expected to take up to 300 days following a formal validation period of the dossier.

In 2023, Clinuvel began treating the first Canadian EPP patient with SCENESSE under Canada's Special Access Program.

The SAP facilitates treatment for patients with serious or life-threatening conditions who lack therapeutic alternatives.

Treatment continues uninterrupted during Health Canada's review, with patients covered by insurance.

Clinuvel's Chief Scientific Officer, Dennis Wright, stated, "The SAP has provided an important bridge for Canadian patients to access treatment and helped us understand the Canadian therapeutic landscape.

"A formal authorisation will enable more Canadian patients to receive SCENESSE and is a logical next step," Wright added.

SCENESSE has demonstrated its ability to prevent and reduce phototoxic reactions and improve the quality of life for EPP patients through international clinical and post-marketing studies.

It is currently approved for use in Europe, the USA, Israel, and Australia.

Clinuvel Pharmaceuticals is a global specialty pharmaceutical company. The company is focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations.