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CLINUVEL’s drug SCENESSE® (afamelanotide) was approved by the US Food and Drug Administration (FDA) on 08 October 2019 for adult patients with erythropoietic protoporphyria (EPP). In June 2019 it was announced that the FDA had requested an extension of the Prescription Drug User Fee Act (PDUFA) date, which was ultimately set on 08 October 2019, when approval was granted. Dr Wolgen provided some more context on this moment in his 2019 Annual Report letter:
On 31 May, the FDA used its discretionary tool to request a three month extension to the formal review user fee goal date, providing a new target date 6 October.* We assessed the delay as a positive measure, since the Agency had had ample opportunity to reject the submission, issue a Refusal to File or even request a withdrawal. None of the events had occurred during our submission or review, and our teams kept working towards satisfying all outstanding questions from the agency. It was a period whereby many around us were tested, but the overwhelming majority of investors kept having faith in our teams. A key ingredient to CLINUVEL’s success continues to be our consistency.
* The FDA later clarified the target date as 08 October 2019, see below.
A brief history of announcements on US regulatory interactions and US clinical trials for EPP to date is provided below.