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Clinuvel Completes Arduous Journey To US Approval Of Scenesse

 
• By Joseph Haas

First-in-class drug for rare disease EPP obtains FDA approval, company plans treatment center-based rollout. Scenesse, on the market in Europe since 2016, has faced reimbursement hurdles.

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Scenesse treats a rare condition that can make a day in the sun painful

Australia’s Clinuvel Pharmaceuticals Ltd. has worked for more than a decade to bring Scenesse (afamelanotide) to the US market for the rare dermatology disorder erythropoietic protoporphyria (EPP), an effort that concluded on 8 October with a delayed approval by the US Food and Drug Administration.

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