Highlights

CLINUVEL’s share price rose 7.22% to AUD 12.03 after EMA amended SCENESSE®’s label to permit dosing every two months.

The updated European label removes the prior maximum dose restriction and harmonises treatment with the U.S. FDA-approved regimen.

CHMP concluded that uninterrupted year-round treatment carries no change to the positive benefit-risk profile, supported by 15 years of clinical and real-world data.

CLINUVEL Pharmaceuticals Limited (ASX:CUV) announced that the European Medicines Agency (EMA) has approved an updated label for its photoprotective drug SCENESSE® (afamelanotide), enabling adult erythropoietic protoporphyria (EPP) patients to receive implants every two months.

The change removes the previous recommendation of a maximum of four implants per year, effectively aligning European prescribing guidance with the U.S. Food and Drug Administration (FDA), where year-round therapy is already in practice.

This variation can be implemented immediately and is expected to improve treatment access for EPP patients across Europe.

CHMP Review Supports Year-Round Use

The Committee for Medicinal Products for Human Use (CHMP) reviewed extensive clinical and real-world data in reaching its conclusion. The package included results from two Phase III clinical trials (CUV039 and CUV029), alongside over 15 years of Real World Evidence gathered through compassionate use, special access, and commercial programs.

The CHMP also examined data on European patients who had received more than four implants in a year, with findings showing no new safety concerns. The Committee confirmed that the overall benefit-risk profile of uninterrupted SCENESSE® therapy remains positive.

CLINUVEL will continue to meet regulatory obligations under its Risk Management Plan for SCENESSE® in Europe. This includes ongoing collection of safety and effectiveness data through the European EPP Disease Registry, the largest global database of EPP patients, containing nearly a decade of treatment records.

About EPP and SCENESSE®

Erythropoietic protoporphyria (EPP) is a rare genetic disorder that causes patients to accumulate high levels of phototoxic compounds, known as protoporphyrins, in the liver and skin. When exposed to visible light, these compounds generate free radicals that damage surrounding tissue.

Patients often experience painful phototoxic reactions from infancy, described as sensations of burning or scalding beneath the skin. These episodes can last days or weeks, leading to scarring and thickening of skin on the face and hands, while severely limiting patients’ ability to function in normal daily life.

EPP also carries major psychosocial consequences, as patients are forced to adapt to avoid light exposure from a young age.

SCENESSE® remains the only approved treatment for EPP worldwide. Clinical studies and real-world experience have demonstrated its ability to reduce the frequency and severity of phototoxic reactions, helping patients engage in daily activities with greater freedom. To date, more than 18,500 SCENESSE® doses have been administered globally.

CUV’s share price rose 7.22% to AUD 12.03 per share at the time of writing on 23 September 2025.