Those who have taken an interest in Clinuvel will have learned with joy that, on Monday February 6th, the company announced its first official filing for SCENESSE® (afamelanotide) with the European Medicines Agency. It has taken our teams around six years to arrive at this point. Benchmarked against peer companies, it is a relatively swift development path for a first-in-class drug; we first publicly announced our erythropoietic protoporphyria (EPP) program in September 2006. It is an opportune moment to reflect briefly on how we reached this milestone and then discuss the steps that must be taken from here. (more…)
Compassionate use – navigating the regulatory landscape to ‘do good’
Friday, December 3rd, 2010
As snow begins to fall around Clinuvel’s European office, the team in Australia is preparing for a long hot summer. The seasons are at the forefront of our minds at Clinuvel, since our lead drug SCENESSE® appears to have a dramatic impact on the ability of patients to expose themselves to sun. We try to test the drug under the most extreme conditions, meaning trials must be conducted in spring and summer. As the seasons change, we begin to see more requests and enquiries from the southern hemisphere, in particular from patients with erythropoietic protoporphyria (EPP), seeking access to the drug outside of formal trial programs. (more…)
Mikey’s story – EPP
Tuesday, September 7th, 2010
Today Clinuvel presents the first in a series of webcast videos featuring 44 year-old Mikey, an Australian man with the severe light intolerance disorder Erythropoietic Protoporphyria (EPP).
EPP is a rare, inherited, metabolic disorder characterised by extreme phototoxicity; toxic reactions to UV and visible light, particularly blue light. The symptoms of this photosensitivity may include those which are not visible to the naked eye, including itching, burning, prickling and most notably, intense pain. (more…)


Held biennially, the Porphyrins & Porphyrias conference (P&P) is the world’s largest gathering on the porphyrias – a group of metabolic disorders causing biochemical disruptions in the pathway of the body which synthesizes haem (heme).
As part of our ongoing focus on erythropoietic protoporphyria (EPP), we’ve invited Victoria to share her experiences with EPP on the blog.



