Clinuvel Pharmaceutical (ASX:CUV) has entered into discussions with the European Medicines Agency (EMA) to increase the recommended maximum annual dose of SCENESSE (amelanotide 16 mg) from four to six doses for patients with erythropoietic protoporphyria (EPP). This change harmonizes European guidelines with those of other regions, including the United States, and allows patients to be treated year-round.

EPP is a rare genetic disease that causes extreme sensitivity to sunlight and certain types of artificial light, leading to painful phototoxic reactions. Patients often experience severe burns and swelling from even the slightest exposure to sunlight, severely limiting their ability to lead a normal life. SCENESSE is administered as a bioabsorbable implant and provides 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 that increasing the dose does not change the safety profile of SCENESSE. The EMA’s Pharmacovigilance Risk Assessment Committee is expected to announce its decision in the first quarter of 2025.

“More than 16,000 doses of SCENESSE have been administered worldwide,” said Dr. Dennis Wright, Clinuvel’s chief scientific officer. “The evidence supports harmonizing doses in Europe and ensuring consistency of treatment options around the world.”

Despite the company’s potential revenue growth discussions, Clinuvel stock closed 1.62% lower at $13.40 today.