MELBOURNE, Australia — CLINUVEL PHARMACEUTICALS LTD today 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.
EMA’s Scientific Advice
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 as the primary endpoint. Patient-reported outcomes and clinical data from other vitiligo studies with SCENESSE® will be evaluated for final analyses of efficacy and safety.
Given the importance of patients’ perceptions of visible change in pigmentation, the EMA emphasised that the assessment by vitiligo patients themselves would play an important role in the final evaluation when vitiligo data from CUV107 and previous studies would be submitted for marketing authorisation. In particular, photographic evidence of change from baseline (CFB) will be used to assess primary and secondary endpoints, T-VASI50 and F-VASI75, with an array of other related secondary objectives. In total, five patient and physician surveys are integrated in the study to record Patient Reported Outcomes.
The EMA advised that patients of darker skin colours (Fitzpatrick IV-V-VI) would benefit from systemic treatment first, since the visibility of disease – due to the contrast between unaffected skin and vitiligo lesions – is most pronounced in these patient groups.
