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October 10, 2019updated 22 Nov 2021 9:59am

Clinuvel obtains US approval for rare disorder drug Scenesse

Australia-based Clinuvel Pharmaceuticals 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.

Australia-based Clinuvel Pharmaceuticals 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 (α-MSH), a natural peptide hormone produced by skin cells in response to the UVR stimulation.

In 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.

Clinuvel Pharmaceuticals chief scientific officer Dr Dennis Wright said: “EPP patients are born with the disease and need to avoid all sources of light exposure, including sunlight throughout their life, or risk incapacitating burns.

“Scenesse is  a  novel  drug  and  formulation,  developed  by  CLINUVEL  to  provide photoprotection for EPP patients, enabling patients to expose to light, providing them a freedom they never had.”

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.

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