has received the US Food and Drug Administration (FDA) approval for the use of Scenesse (16mg afamelanotide) to treat erythropoietic protoporphyria (EPP), which results in absolute intolerance to light.
The drug is indicated to improve pain-free light exposure in adults with a history of phototoxic reactions due to EPP.
EPP is a rare, genetic, metabolic disorder that impacts the heme biosynthesis pathway, leading to lifelong phototoxicity due to the accumulation of protoporphyrin IX (PPIX) in the blood and tissues.
Upon exposure to visible light and near-visible ultraviolet radiation, PPIX becomes active, causing damage to surrounding tissue. EPP patients are known to experience severe pain under the skin.
Scenesse is a photoprotective subcutaneous implant that binds to the melanocortin-1 receptor on skin cells and increases the melanin levels in the skin as well as protects from and sunlight and UV radiation (UVR).
The drug is a chemical analogue of alpha-melanocyte-stimulating hormone (伪-MSH), a natural peptide hormone produced by skin cells in response to the UVR stimulation.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataIn 2014, the European Medicines Agency approved the drug for EPP treatment. Scenesse is administered as a 16mg controlled-release implant, offering protection for up to 60 days.
chief scientific officer Dr Dennis Wright said: 鈥淓PP patients are born with the disease and need to avoid all sources of light exposure, including sunlight throughout their life, or risk incapacitating burns.
鈥淪cenesse is聽 a聽 novel聽 drug聽 and聽 formulation,聽 developed聽 by聽 CLINUVEL聽 to聽 provide photoprotection for EPP patients, enabling patients to expose to light, providing them a freedom they never had.鈥�
According to the company, Scenesse has been used to treat more than 800 patients across over 20 clinical trials. Data indicated that the drug is well-tolerated and can reduce the incidence and severity of phototoxic reactions.
