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United States Drug Review Innovation

Clinuvel’s US Filing For EPP Drug Scenesse Includes Real World Evidence From Europe

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Executive Summary

Clinuvel says real world evidence from the experience of European patients is a key part of the submission it has just made to the US FDA for its ground-breaking phototoxicity therapy, Scenesse (afamelanotide). The company also plans to apply its one-price policy for the product in the US.

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