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- American Biopharmaceutical company CLINUVEL has been awarded a priority registration by the TGA to help bring their drug for EPP sufferers to market
- The Fastrack means the TGA will conduct a priority review of the drug within the next 150 days
- SCENESSE is the company’s flagship drug, an implant which acts against EPP by increasing levels of melanin in the skin to shield against UV radiation
- CLINUVEL stocks rose 2.17 per cent today, currently trading at A$32.04 each
CLINUVEL is one step closer to getting its new drug to market after being awarded a priority registration by the TGA.
The Australian Therapeutic Goods Administration (TGA) has Fastracked SCENESSE, a new drug which treats patients suffering from light sensitivity as a result of erythropoietic protoporphyria (EPP).
The Fastrack means the TGA will conduct a priority review of the drug within the next 150 days.
CLINUVEL’s Chief Scientific Officer Dr Dennis Wright said the submission of scientific data to the TGA was well in line with the company’s plan to bring the drug to market.
“Australian EPP patients have been waiting for a long time, given they received the drug treatment during the last trials in 2010,” Dr Wright said.
SCENESSE is the company’s flagship drug, an implant which acts against EPP by increasing levels of melanin in the skin to shield against UV radiation.
According to the American Poryphia Foundation, EPP is a rare genetic metabolic disorder. It’s characterised by a missing enzyme, FECH, which causes excessive amounts of protoporphyrin to accumulate in the body. As a result, sufferers experience hypersensitivity to sunlight and irritation on their skin.
Although the drug has just received TGA registration, SCENESSE received orphan drug categorisation back in 2010. The treatment was also approved by the U.S.’s Food and Drug Administration (FDA) earlier this month.
From here, the company intends to provide a research dossier about SCENESSE to the TGA within the first quarter of next year.
CLINUVEL is based in Victoria, where the ASX-listed pharmaceutical company manages a number of global projects. The Australian company also oversees three other treatments under pipeline classification.
CLINUVEL stocks rose 2.17 per cent today, currently trading at A$32.04 each. The company’s market cap is sitting at just over A$1.5 billion.
