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

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