Clinuvel Is Planning For US Commercialization Of Ultra-Orphan Drug Scenesse
Clinuvel's Scenesse for the ultra-rare, light-induced disease erythoropoietic protoporphyria (EPP) is already approved in Europe and the company is hopeful that a rolling NDA submission could pave the way for a US launch.
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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.
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.
This month should see the outcome of a public hearing held to discuss the decision by the UK's health technology assessment body, NICE, not to recommend funding for Clinuvel’s Scenesse, a novel treatment for the ultra-rare condition, erythropoietic protoporphyria.