Clinuvel Pharmaceuticals (ASX:CUV) has entered discussions with the European Medicines Agency (EMA) to increase the recommended maximum annual dosage of SCENESSE (afamelanotide 16mg) for patients with erythropoietic protoporphyria (EPP) from four to six doses. This change would harmonise European guidelines with those in other regions, including the United States, enabling year-round treatment for patients.
EPP is a rare genetic disorder that causes extreme sensitivity to sunlight and certain artificial lights, leading to painful phototoxic reactions. Patients often experience severe burns or swelling after minimal exposure to sunlight, significantly limiting their ability to lead normal lives. SCENESSE is administered as a bioresorbable implant, offering photoprotection that reduces the incidence and severity of painful reactions.
Clinuvel’s submission to the EMA is supported by clinical and real-world evidence showing no change in the safety profile of SCENESSE with increased dosage. The EMA’s Pharmacovigilance Risk Assessment Committee is expected to announce a decision in the first quarter of 2025.
“Over 16,000 doses of SCENESSE have been administered globally,” said Dr Dennis Wright, Clinuvel’s Chief Scientific Officer. “The evidence supports harmonising European dosage, ensuring consistency in treatment options worldwide.”
Despite the potential of the discussions for increased revenue for the company, shares in Clinuvel closed 1.62% lower today at $13.40.
