Clinuvel pharmaceutical products (ASX:CUV) has entered into discussions with the European Medicines Agency (EMA) to increase the maximum recommended annual dose of SCENESSE (afamelanotide 16 mg) for patients with erythropoietic protoporphyria (EPP) from four to six doses. This change would harmonize European guidelines with those of other regions, including the United States, allowing patients to be treated year-round.
EPP is a rare genetic disorder that causes extreme sensitivity to sunlight and some 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 a normal life. SCENESSE is administered as a bioabsorbable 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 increasing 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, chief scientific officer of Clinuvel. “The evidence supports European dosing harmonization, ensuring consistency in treatment options around the world.”
Despite the potential of discussions for increased revenue for the company, Clinuvel shares closed 1.62% lower at $13.40 today.