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Clinuvel Pharmaceuticals Limited
We are a global biopharmaceutical company committed to developing drugs for the treatment of a range of severe skin disorders.
Our website has been developed to help share our expertise on the interaction of light and human skin as well as provide a thorough overview of our global drug development programs.
CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe.
In December 2014 the European Commission granted SCENESSE® marketing authorisation under exceptional circumstances for the prevention of phototoxicity in adult patients with EPP.
In October 2019, the US FDA granted CLINUVEL marketing approval for SCENESSE® (afamelanotide 16mg) to increase pain free light exposure in adult patients with a history of phototoxic reactions from EPP.
Further trials of SCENESSE® are underway in the pigmentary disorder vitiligo
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News
Clinuvel Pharmaceuticals – Minimal Concerns Over FDA Delay
Investors were quick to drop Clinuvel shares after an update on the Prescription Drug User Fee Act (PDUFA) goal date for its SCENESSE product. However, analysts at Moelis note that while any delay around FDA approval is disappointing, it's likely only a timing issue.
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