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Media Release – TGA approves Australian drug to protect patients from light and sun

New Australian-developed drug approved by TGA for metabolic disorder erythropoietic protoporphyria (EPP)

A new drug developed by biopharmaceutical company CLINUVEL has received approval to be prescribed in Australia for a rare light intolerance disorder. SCENESSE® (afamelanotide) was developed by the Australian-led team to protect patients with the metabolic disorder erythropoietic protoporphyria (EPP) and will soon be listed on the Australian Therapeutic Goods Register following approval from the Therapeutic Goods Administration (TGA).

“EPP patients suffer phototoxic reactions – incapacitating deep burns which lasts for days – when exposed to light, including sunlight,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “They are forced to socially isolate and shelter from all light exposure throughout life to protect from burning.

“SCENESSE® is the first treatment to provide EPP patients protection from the wavelengths of light that cause phototoxicity, by reducing the number and severity of reactions and increasing the amount of time they can expose to light. Most satisfyingly, since the drug has been made available in Europe in 2016 and the US in 2020 respectively, these patients report being given a freedom they never had imagined and now they are trying to make up for decades of restricted existence.” 

EPP is an inherited metabolic disorder which causes lifelong and severe reactions to light exposure (phototoxicity). Patients experience debilitating second degree burns which last weeks and force them to avoid all further exposure to light. There are an estimated 5,000 to 10,000 EPP patients worldwide, with approximately 180 patients across Australia.

SCENESSE® will be registered in Australia for the indication prevention of phototoxicity in adult patients with EPP. The drug will be available as a prescription medication in Australia, to be administered by trained and accredited healthcare professionals. CLINUVEL will implement a comprehensive training and accreditation program and ensure that healthcare professionals are provided with information in line with the Australian approval.

SCENESSE®, which is approved in Europe and the USA for EPP, is the world’s first systemic photoprotective drug, providing the entire body protection against light sources and UV. The drug contains the active ingredient afamelanotide, which binds to skin cells and sets in motion a number of cellular events, acting as a strong antioxidant drug and optimising the blood flow in the skin.

Over 10,000 doses of afamelanotide have been administered to over 1,400 individuals during the past two decades. SCENESSE® is administered as a 16mg controlled-release injectable implant, with the Australian approved dosing regimen of one implant every two months.

“Our team is delighted that an Australian innovation is returning home as an approved drug and will be made available for Australian EPP patients,” Dr Wright said. “I recognise the work of patients, physicians, TGA staff and our team to facilitate today’s outcome, which is the result of many years of engagement and dialogue. Our objective has been clear: to find ways to enable all EPP patients worldwide to access the first ever treatment for this disorder which is largely misunderstood but which causes patients a lifelong imprisonment, away from a normal outdoor life.”

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Notes to editors:
A longer technical release has been issued to the Australian Securities Exchange and is available on CLINUVEL’s website www.clinuvel.com. 

SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase “pain- free” light exposure in adult EPP patients with a history of phototoxicity. Information on the product can be found on CLINUVEL’s website at www.clinuvel.com.

Phase III clinical trials of SCENESSE® have been published in the New England Journal of Medicine, see: Langendonk et al (2015). Afamelanotide for Erythropoietic Protoporphyria. NEJM. 373(1):48-59. Online at https://www.nejm.org/doi/10.1056/NEJMoa1411481. Long-term data from the post-authorisation use of SCENESSE® in Europe have been published in JAMA Dermatology, see: Wensink et al (2020). Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice. JAMA Dermatol. 156(5):570-575. Abstract at https://pubmed.ncbi.nlm.nih.gov/32186677/.

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