2016 Announcements
FDA SCHEDULES PRE-NDA MEETING FOR SCENESSE®
12 October 2016
On 7 November the US Food and Drug Administration (FDA) will hold a meeting with CLINUVEL to discuss the submission a New Drug Application (NDA) for SCENESSE® (afamelanotide 16mg) in the treatment of erythropoietic protoporphyria (EPP).
Executive summary:
- The FDA scheduled a pre-NDA1 meeting on 7 November to discuss CLINUVEL’s planned US regulatory submission for SCENESSE®
- A key focus will be the establishment of Risk Evaluation and Mitigation Strategies (REMS) and post-authorisation safety measures
- Under Fast Track Designation² – one of FDA’s Expedited Programs for Serious Conditions – submission of the NDA is allowed on a rolling basis
- Application fees waived for the orphan drug designated3 product SCENESSE®
- On 24 October the FDA will hold an EPP Workshop with patients and physicians to gain a better understanding of the disease