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Clinuvel Press Release
FDA awards SCENESSE® Fast Track designation for treatment of EPP
Clinuvel Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has granted SCENESSE (afamelanotide 16 mg) Fast Track designation for the treatment of erythropoietic protoporphyria (EPP).
This designation recognises the severity of EPP and the unmet medical need of the disorder in the US.
SCENESSE is commercially available for EPP patients in Europe.
What about Rosacea?
Despite not being currently targeted as rosacea treatment, SCENESSE remains interesting for rosacea sufferers who identify exposure to the sun as a significant trigger for their symptoms.
Whilst EPP is a very different condition to rosacea, it may be possible to explore SCENESSE as an off label treatment for rosacea in the future.
Comments via email.
“I have rosacea and Polymorphous Light Eruption. Has Scenesse been approved in the US for this photosensitive condition? Thx.”
Some info here
http://www.clinuvel.com/en/scenesse/clinuvels-program-polymorphous-light-eruption-ple
No idea when/if it will become available though.
“thank you so much. I’ve been trying to get into a clinical study but maybe my dr. will try it “off label” for pLE now that it’s approved in the U.S.”