Clinuvel Secures EMA Scientific Advice for 300Patient Vitiligo Study
Clinuvel Pharmaceuticals has secured EMA scientific advice for its Clinuvel Phase III Vitiligo Study, clearing the regulatory pathway for a 300-patient pivotal trial of SCENESSE set to commence in the second half of 2026.
Key Takeaways
- Clinuvel has received final scientific advice from the EMA for its pivotal Phase III CUV107 study after over 12 months of regulatory dialogue including two formal submissions.
- The 300-patient trial evaluating SCENESSE (afamelanotide) for non-segmental vitiligo is scheduled to commence in the second half of 2026, targeting adults and adolescents.
- The EMA will apply a "totality of evidence" approach to evaluate efficacy, allowing Clinuvel to integrate data from multiple prior vitiligo studies alongside CUV107.
- No approved therapies currently exist for patients with extensive depigmentation affecting more than 10% of total body surface area, representing a significant commercial opportunity for a first systemic treatment.
- The EMA specifically advised that patients with darker skin tones (Fitzpatrick skin types IV-V-VI) would benefit first, establishing a defined priority population for the study.
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