Erythropoietic Protoporphyria (EPP)

About EPP

Erythropoietic Protoporphyria

EPP is a rare metabolic disorder that causes severe anaphylactoid reactions to light (phototoxicity).

Patients incur physical burns and ulcers, and are in a state of crisis following light exposure, summarised as phototoxicity. This usually occurs within minutes of exposure to light, especially high energy visible (HEV)/solar radiation.

Children and adults living with EPP must avoid sunlight and even reflected light for life, often staying indoors or wearing protective clothing. Conventional sunscreens have little to no effect as they do not block the wavelengths of light which cause phototoxicity in EPP.

EPP symptoms can be acute, or delayed (subacute), and are most often expressed as generalised oedema, effusion in tissue and scarring of the skin. As little as a few minutes of light outdoors (even when it is overcast or transmitted through a window) or artificial light exposure may be sufficient to evoke EPP symptoms.

Phototoxicity is unresponsive to traditional pain and burn management techniques and patients can be incapacitated for days before reactions subside. Most patients must withdraw from light exposure in order to manage their phototoxic symptoms.

Approximately 10,000 people globally are affected by EPP.


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Clinical Results

January 2009

CLINUVEL announced interim results from its lead Phase III study of SCENESSE® (afamelanotide 16mg) in patients diagnosed with EPP (CUV017). The data from the first 14 Swiss patients to complete the 12 month study period were analysed, showing SCENESSE® was of clinical benefit in EPP.

December 2009

CLINUVEL announced preliminary results from its lead Phase III study of SCENESSE® in 100 patients diagnosed with EPP (CUV017).

July 2010

CLINUVEL released full report from the CUV017 study.

November 2011

CLINUVEL announced results from its first US Phase II study of SCENESSE® (afamelanotide 16mg) (CUV030).

November 2013

CLINUVEL announced results from its US Phase III study of SCENESSE® (afamelanotide 16mg) (CUV039).

Clinical and
regulatory progress

December 2014

SCENESSE® (afamelanotide 16mg) approved by European Medicines Agency (EMA).

October 2019

US Food and Drug Administration grant marketing approval for SCENESSE®.

April 2020

Partnership with HK Winhealth Pharma Group Co. Limited in China announced.

October 2020

SCENESSE® approved by the Australian Therapeutic Goods Administration (TGA).

February 2021

Market access granted in Israel.

September 2022

CLINUVEL submitted a variation to its marketing authorisation dossier for SCENESSE® to the EMA, providing scientific data supporting the expansion of the authorised indication to include adolescent patients aged 12 years and older. In parallel, the Company has updated its paediatric investigation plan for SCENESSE® to reflect the proposed label expansion. Read the announcement.


CLINUVEL is working to facilitate access to EPP patients in a number of countries. For more specific info, please contact us.


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