• 'Totality of evidence' approach to evaluate SCENESSE® by EMA
• Photographic evidence and validated disease assessment tools agreed
• CUV107 study to compare SCENESSE® with adjunct NB-UVB vs NB-UVB monotherapy

Clinuvel Pharmaceuticals announced that the European Medicines Agency (EMA) has provided final scientific advice on the design of the planned pivotal Phase III CUV107 study and anticipated evaluation of evidence of Clinuvel's drug SCENESSE® (afamelanotide) as a systemic vitiligo treatment. Following over 12 months of interaction, two formal submissions and a Discussion Meeting with the EMA's Scientific Advice Working Party (SAWP), the Committee for Medicinal Products for Human Use (CHMP), has issued Scientific Advice on Clinuvel's program evaluating SCENESSE® as a systemic therapy for adults and adolescents with non-segmental vitiligo. The EMA proposed to evaluate the efficacy of SCENESSE® in vitiligo based on a regulatory approach of 'totality of evidence', with T-VASI50 the primary endpoint while patient reported outcomes and clinical data from the other vitiligo studies with SCENESSE® will be evaluated for final analyses of efficacy and safety. The EMA advised that patients of darker skin colours (Fitzpatrick IV-V-VI) would benefit from systemic treatment first, since the visibility of disease is most pronounced in these patient groups. The CUV107 study (n=300) is expected to commence in the second half of 2026.