Clinuvel drug approved in Europe for rare sun disorder

28-Oct-2014 - Clinuvel Pharmaceuticals Ltd has announced that its drug SCENESSE® (afamelanotide 16mg) has received its first approval from the European Medicines Agency (EMA) to treat a disease caused by exposure to sunlight. The EMA’s Committee for Medicinal Products for Human Use (CHMP) voted in favour of ...

Clinuvel commences US Phase III trial of SCENESSE in rare light and UV disorder

US registration study in erythropoietic protoporphyria (EPP) underway

24-May-2012 - Clinuvel Pharmaceuticals Limited announced that it has commenced its confirmatory Phase III US study of the novel drug SCENESSE® (afamelanotide) in patients diagnosed with the rare light intolerance disorder erythropoietic protoporphyria (EPP). The six-month, randomised, multicentre, ...

Clinuvel files European marketing authorisation application for SCENESSE (afamelanotide)

European regulators to evaluate new drug’s safety and efficacy for ‘orphan’ disease erythropoietic protoporphyria (EPP)

08-Feb-2012 - Clinuvel Pharmaceuticals Limited announced that it has submitted a marketing authorisation application (MAA) for its first-in-class drug SCENESSE® (afamelanotide 16mg implant) to the European Medicines Agency (EMA). The MAA covers the use of SCENESSE® as a prophylactic treatment in adult patients ...

Clinuvel announces positive results from pivotal European Phase III study: endpoints demonstrate clinically relevant treatment effect of afamelanotide

21-Dec-2011 - Clinuvel Pharmaceuticals Limited announced that final analyses of its confirmatory Phase III European study (CUV029) in erythropoietic protoporphyria (EPP) has shown a clinically relevant positive prophylactic treatment effect for patients who had been administered SCENESSE® (afamelanotide 16mg ...

Clinuvel's afamelanotide to commence US patient trials for absolute light intolerance

30-Mar-2010 - An Australian drug to protect patients who are intolerant of light and sunlight will begin trials in the US next month. The US Food and Drug Administration (FDA) has given clearance to Melbourne’s Clinuvel Pharmaceuticals to commence a Phase II study (CUV030) of its drug, afamelanotide, in up to ...

Breakthrough drug for people intolerant of sunlight

22-Dec-2009 - A new pharmaceutical drug which protects people from sunlight may revolutionise preventative treatments for patients with a range of light-sensitive skin disorders. A 12 month trial of the drug, afamelanotide, has just been completed on patients with Erythropoietic Protoporphyria (EPP), a ...

Clinuvel announces PLE Phase III preliminary results

Trial in polymorphic light eruption (PLE) to support the final registration dossier of afamelanotide

18-Dec-2009 - Clinuvel Pharmaceuticals Limited announced that it has obtained preliminary results in its multicenter randomised double-blind placebo controlled PLE study (CUV015) evaluating the safety and efficacy of afamelanotide 20 mg implants. PLE is a recurrent seasonal UV-related skin disorder seen mostly ...

Clinuvel: positive interim Phase III results for unique skin protection drug

Photoprotective drug afamelanotide moves a step closer to market

26-Jan-2009 - Melbourne-based Clinuvel Pharmaceuticals Limited achieved positive interim results of its photoprotective drug, afamelanotide, in a Phase III trial conducted in Switzerland. The trial investigated the medical benefits of afamelanotide in the orphan disease erythropoietic protoporphyria (EPP), a ...