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Clinuvel Completes Arduous Journey To US Approval Of Scenesse

Executive Summary

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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Clinuvel Provides EPP Therapy Scenesse To Chinese Patients

Individual patients in China will soon be able to gain access to Scenesse, a groundbreaking therapy for the rare phototoxicity disorder, erythropoietic protoporphyria, under a named patient program, pending the submission of a formal approval application. The product’s developer, Clinuvel, says it is currently awaiting a response on its filing with the Australian regulator and that it has other markets such as Japan in its sights.

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US FDA Needs More Time To Review Clinuvel’s Scenesse For Phototoxicity

The user fee goal date for the Food and Drug Administration’s review of Scenesse has been put back from July to October to allow more time to examine the therapy’s benefit-risk profile.

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