Clinuvel has finally completed a new drug application (NDA) filing in the US for its phototoxicity drug Scenesse and expects an approval or complete response letter for the product sometime in 2019. The exact timing will be partly dependent on whether the Food and Drug Administration accepts the company’s request for a priority review.
CEO Philippe Wolgen said the company had taken advantage of the FDA’s increasing openness to real world evidence (RWE) by including data from EU patient experiences in the US filing, and that it planned to