Scenesse fast tracked for EPP in US

Written by on July 12, 2016 in Scenesse (Afamelanotide Implant 16mg) with 3 Comments
Scenesse continues to receive approvals for use in special cases, this time being given fast track designation status for the treatment of erythropoietic protoporphyria in the US. This approval comes after SCENESSE was granted general availability in Europe for treating EPP.

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.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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3 Reader Comments

  1. Comments via email.

    “I have rosacea and Polymorphous Light Eruption. Has Scenesse been approved in the US for this photosensitive condition? Thx.”

  2. “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.”

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