CLINUVEL’s SCENESSE® Gains EMA Approval for Unlimited Bi-Monthly Dosing

Regulatory Shift in EPP Treatment

The European Medicines Agency (EMA) has taken a significant step in the management of erythropoietic protoporphyria (EPP) by approving a label amendment for CLINUVEL Pharmaceuticals’ SCENESSE® (afamelanotide). This change permits adult patients to receive the photoprotective implant every two months throughout the year, effectively removing the previous recommended cap of four implants annually.

This regulatory update harmonises the European treatment protocol with that of the United States, where year-round dosing has been common practice. The decision follows a comprehensive review by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which evaluated extensive clinical trial data alongside real-world evidence accumulated over 15 years.

Data-Driven Confidence

The CHMP’s positive opinion reflects a robust benefit-risk profile for continuous SCENESSE® administration. The committee scrutinised data from pivotal Phase III studies and real-world patient outcomes, particularly focusing on safety and efficacy in patients receiving more than four implants per year. Their conclusion – no significant safety concerns arise from uninterrupted dosing, a critical endorsement for patients suffering from this debilitating condition.

CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright, highlighted the importance of this milestone, noting that the expanded data pool now supports year-round treatment. He also pointed out the synergy between EPP and vitiligo programs, where SCENESSE® is administered even more frequently, further reinforcing the drug’s safety profile.

Addressing a Debilitating Condition

EPP is a rare genetic disorder causing extreme sensitivity to visible light due to the accumulation of phototoxic compounds in the body. Patients endure severe skin reactions that can incapacitate them for days or weeks, often leading to chronic skin damage and profound lifestyle restrictions. SCENESSE® remains the only approved systemic therapy that mitigates these phototoxic effects, enabling patients to regain a degree of normalcy.

With over 18,500 doses administered globally, the drug’s real-world impact is substantial. The EMA’s approval to remove dosing restrictions is expected to enhance patient access and treatment flexibility across Europe.

Ongoing Vigilance and Future Outlook

Despite this regulatory progress, CLINUVEL commits to rigorous post-approval monitoring through the European EPP Disease Registry, which holds nearly a decade’s worth of patient data. This ongoing surveillance will be crucial to ensuring long-term safety and effectiveness as year-round dosing becomes standard practice.

For investors and patients alike, this development signals a maturation of the SCENESSE® program and a potential expansion of its market footprint. It also underscores the evolving landscape of photomedicine, where data-driven regulatory decisions are paving the way for improved patient outcomes.