CLINUVEL's strategic EMA discussions

CLINUVEL Pharmaceuticals (ASX:CUV) is in advanced talks with the European Medicines Agency (EMA) to potentially expand the dosage recommendations for SCENESSE®. The proposal aims to increase the maximum annual doses from four to six for treating erythropoietic protoporphyria (EPP). The EMA is reviewing real-world and long-term usage data provided by the company. A decision is expected in early 2025.

SCENESSE® dosage expansion and future outlook

CLINUVEL Pharmaceuticals is actively working with the EMA to expand the dosage recommendations for SCENESSE®, aiming to increase the maximum annual doses for EPP treatment. The current European label allows for four implants per year, but new data suggests a stable safety profile for increased frequencies. The discussions reflect a significant demand from the medical community and patients for more frequent dosing, aligning with guidelines in other regions like the USA. CLINUVEL is committed to harmonising global treatment standards through rigorous risk management and data collection. The outcome of these discussions is anticipated in the first quarter of 2025, potentially enhancing the quality of life for EPP patients worldwide.

Insights from CLINUVEL on EMA discussions

There is significant demand from expert physicians and patients to expand the EU SCENESSE® label to allow more frequent dosing, ensuring year-round treatment. Although the current European label suggests a maximum of four implants annually, many patients are already receiving more frequent doses with a stable safety profile.