Clinuvel in Talks with European Regulators Over Dosage Expansion for Metabolic Disorder Drug

MT Newswires Live

Nov 20, 2024

Clinuvel Pharmaceuticals (ASX:CUV) said it is in talks with the European Medicines Agency (EMA) to increase the recommended maximum dose of its drug Scenesse for adult patients with erythropoietic protoporphyria (EPP), according to a Wednesday filing with the Australian bourse.

EPP is an inherited condition characterized by extreme photosensitivity and could lead to liver disease.

The EMA's Pharmacovigilance Risk Assessment Committee will decide whether to maintain the existing drug label or expand it to up to six times per year, the filing said.

The outcome is expected by the first quarter of 2025, according to the filing.

Clinuvel Pharmaceuticals' shares were down more than 2% in recent Wednesday trade.

Price (AUD): $13.30, Change: $-0.32, Percent Change: -2.39%

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