2019 Announcements

SCENESSE® registration dossier submitted in Australia

CLINUVEL initiates the registration process under priority review for its new pharmaceutical drug.

CLINUVEL PHARMACEUTICALS LTD today announced that it has submitted an application to the Australian Therapeutic Goods Administration (TGA) for its drug SCENESSE® (afamelanotide 16mg) to be registered in the Australian Register of Therapeutic Goods (ARTG).

If registered, SCENESSE® would be made available by prescription in Australia for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).


Under Section 25 of the Therapeutic Goods Act 1989, a delegate of the Secretary of the Department of Health is responsible to register pharmaceutical products on the ARTG following scientific review of a technical dossier containing data on a drug’s quality, safety and efficacy. During the evaluation period the TGA is expected to issue questions to be addressed within set timelines, and clock stops may be applied to enable exchange on specific questions or issues. All submissions are initially scheduled to be evaluated by the Advisory Committee on Medicines, although committee advice may not be required.

SCENESSE® was granted an orphan drug designation by the TGA in November 2010, recognising its intended use in EPP. In October 2019 the TGA assigned SCENESSE® a Priority Application, granted under Part 3C of the Therapeutic Goods Regulations 1990. Under Priority Review a targeted timeframe of 150 working days for scientific evaluation is set, calculated from the first day the dossier is accepted for evaluation. The TGA must make a preliminary assessment of the submission prior to its formal acceptance.


EPP is a rare metabolic disorder which causes severe phototoxic reactions (anaphylactoid reactions and burns) when patients expose their skin surface to visible light. Afamelanotide, the active ingredient in SCENESSE®, acts as an antioxidant and stimulates the production of melanin in skin to prevent phototoxic reactions in EPP patients. SCENESSE® is the world’s first systemic photoprotective drug.

CLINUVEL is the first company to have developed a treatment for EPP patients, with clinical trials of SCENESSE® commencing in EPP patients in 2006. Australian EPP patients were involved in clinical trials between 2007 and 2009. Following clinical trials, patients requested ongoing access to treatment which was facilitated for up to a year (six doses) in Australia under compassionate use.

There are currently no approved treatments for EPP in Australia. SCENESSE® has been granted marketing authorisation in the USA (FDA) and Europe (EMA) for adult EPP patients.1


“We are delighted to file for registration of SCENESSE® in Australia, most of all for Australian EPP patients who have been requesting the treatment since our first clinical trials,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “We have engaged with the TGA over many years to discuss the technical aspects of our dossier and arrive at a submission. Since the US approval of SCENESSE® on October 8, our team has accelerated the dossier preparation to fulfill the requirements for filing the Australian dossier. Before engaging with the TGA, we now have to wait for completion of the dossier validation step.”

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1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with 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.

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