Clinuvel Pharmaceuticals Limited (AU:CUV) has released an update.
Clinuvel Pharmaceuticals Limited has withdrawn its application to extend the use of SCENESSE® for adolescent erythropoietic protoporphyria (EPP) patients in Europe, following extensive discussions with the European Medicines Agency. Despite the setback, the company plans to collect additional data and refile, and continues to supply the drug to adolescents via reimbursement and compassionate access programs. SCENESSE® remains the only approved therapy for adult EPP, which is a rare genetic disorder causing severe light intolerance.
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