The SCENESSE® (afamelanotide 16mg) Package Information Leaflet (English PDF) can be accessed here. The SCENESSE® (afamelanotide 16mg) Summary of Product Characteristics (English PDF) can be accessed here. Information in languages other than English available on the European Medicines Agency’s website here (external link).
SCENESSE® (INN: afamelanotide) is CLINUVEL’s proprietary first-in-class photoprotective drug. The drug has been approved for marketing authorisation under exceptional circumstances by the European Medicines Agency for the prevention of phototoxicity in adults with the orphan disease erythropoietic protoporphyria (EPP). In June 2018 CLINUVEL submitted a new drug application with the US FDA seeking marketing authorisation for SCENESSE®. Further studies of SCENESSE® are underway as a repigmentary agent in vitiligo.
In October 2018, CLINUVEL announced that a Phase IIa proof of concept study (CUV040) evaluating SCENESSE® in variegate porphyria (VP) is expected to start patient treatment in the northern hemisphere spring of 2019.
SCENESSE® (pronounced “sen-esse”) acts by increasing the levels of melanin in the skin; and shields against UV radiation (UVR) and sunlight. SCENESSE® is delivered via a subcutaneous dissolving implant approximately the size of a grain of rice. Increased pigmentation of the skin appears after two days and lasts up to two months.
Alpha-Melanocyte Stimulating Hormone (α-MSH) is a naturally occurring peptide hormone which is released by skin cells in response to the stimulation by ultraviolet radiation (UVR). α-MSH has a very short half-life (seconds) in the blood stream, sufficient to reach and stimulate other skin cells (melanocytes) which in turn produce and release melanin, a dark brown pigment. Melanin is known for its photoprotective effect.
SCENESSE® is a chemical analogue of α-MSH and is a linear peptide with 13 amino acids. Two amino acids present in α-MSH have been changed and amplified to produce afamelanotide. This small change creates a more stable molecule with increased potent biologic effects and a longer half-life (minutes). SCENESSE® increases melanin content of the skin without exposure of the skin to the damaging effects of UVR.
CLINUVEL is currently trialling SCENESSE® in a range of light and UV related skin disorders (photodermatoses) and as a repigmentation therapy in vitiligo. It is proposed that SCENESSE® will provide prophylactic treatment to patients suffering from photodermatoses by stimulating melanin to act as a photoprotective filtering the impact of UV to the skin. In vitiligo the drug is being evaluated in combination with narrowband ultraviolet B phototherapy (NB-UVB).
Over 800 patients have been treated with SCENESSE® in more than 20 clinical trials over several indications. Results to date suggest that the drug is well tolerated. In EPP trials, SCENESSE® has been shown to reduce the incidence and severity of phototoxic reactions.
CLINUVEL PHARMACEUTICALS LTD is an ethical pharmaceutical company focused on providing photoprotective care of the skin. CLINUVEL is working closely with global regulatory agencies to develop SCENESSE® as a prescriptive drug. CLINUVEL has been developing and testing SCENESSE® since 2000. Our development is focused on the SAFE and controlled administration of the drug substance.