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- Clinuvel Pharmaceuticals (CUV) has received approved registration from the Therapeutic Goods Administration (TGA) for its Scenesse drug
- Scenesse is used in the prevention of skin irritation in adult patients with erythropoietic protoporphyria (EPP)
- EPP is an inherited disorder which causes burns and internal damage to vessels when patients are exposed to light
- Scenesse is a photo-protective drug which acts as an anti-oxidative, strengthens blood vessels and reduces swelling
- It will be available as a prescription medication and will be administered by trained and accredited healthcare professional every two months
- Clinuvel has ended the day 1.55 per cent in the red with shares trading for $21.61 each
Clinuvel Pharmaceuticals (CUV) has received approved registration from the Therapeutic Goods Administration (TGA) for its Scenesse drug.
Scenesse is used in the prevention of phototoxicity (skin irritation) in adult patients with erythropoietic protoporphyria (EPP).
EPP is an inherited disorder which causes burns and internal damage to vessels whenever patients are exposed to visible light, particularly sunlight or fluorescent lighting.
When exposed to light, patients may experience tingling, itching and burning of the skin. Continued exposure may make the skin become red and swollen.
While the hands and face are the most commonly affected areas, some people may also have complications in the liver or gallbladder.
As it’s easier to remain indoors, those with EPP are traditionally deprived of social settings and outdoor activities.
This TGA approval of Scenesse is the first treatment approved for EPP patients in Australia.
Scenesse is a photo-protective drug that acts as an anti-oxidative, strengthens blood vessels and reduces swelling. It increases the levels of melanin in the skin and shields against UV radiation.
Studies have shown it reduces the severity and occurrence of phytotoxic reactions and increases the number of time patients can be exposed to light.
Scenesse will be registered in Australia for “the prevention in adult patients with EPP”.
It will be available as a prescription medication and will be administered by a trained and accredited healthcare professional every two months.
“It is deeply satisfying to share with all involved that Scenesse has been approved to treat Australian EPP patients,” Chief Scientific Officer Dr Dennis Wright commented.
“Our stepwise approach to regulatory engagement continues to be validated by today’s news while we progress discussions in other regions where EPP patients lack access to treatment,” he said.
Clinuvel has ended the day 1.55 per cent in the red with shares trading for $21.61 each in a $1.084 billion market cap.
