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Clinuvel Is Planning For US Commercialization Of Ultra-Orphan Drug Scenesse

 
• By Jessica Merrill

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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Clinuvel Pharmaceuticals Ltd. launched Scenesse (afamelanotide) in Europe in 2016 and now the company is preparing a similar commercialization and pricing strategy for the ultra-orphan drug in the US. The company has submitted a rolling NDA to the FDA for Scenesse for patients with erythropoietic protoporphyria (EPP), an ultra-rare condition that causes severe reactions to light, or phototoxicity.

The company, based in Melbourne Australia, announced the rolling new drug application (NDA) submission in June, but on Sept. 5 the company said the FDA has requested additional information related to manufacturing and the use of the drug in Europe

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