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.
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.