After the completion of our first Phase III study of SCENESSE® (afamelanotide) in individuals diagnosed with the rare disease erythropoietic protoporphyria (EPP), Clinuvel received a large number of requests from patients and physicians involved in the study to continue treatment with the drug. The company agreed and continued supply of the drug free of charge for 12 months to approximately 90% of the patients involved in this study. This was largely possible through programs in individual countries often referred to as ‘compassionate use’ or ‘special access’.
Clinuvel supports the use of SCENESSE® for all EPP patients involved in our studies where this use can be facilitated. We firmly support those involved in our EPP program being able to access the drug prior to its approval and work with regulatory authorities to provide this access wherever possible.