CLINUVEL PROVIDES UPDATE ON SCENESSE® FDA FILING

19 September 2017

CLINUVEL PHARMACEUTICALS LTD  today announced an update on its submission of the New Drug Application (NDA) for CLINUVEL’s drug SCENESSE® (afamelanotide 16 mg) to the US Food and Drug Administration (FDA).

  • EUROPEAN POST-MARKETING SAFETY DATA TO BE SUBMITTED AS PART OF NEW DRUG APPLICATION (NDA), EXPECTED IN DECEMBER 2017
  • NO RISK EVALUATION & MITIGATION STRATEGIES (REMS) EXPECTED BUT A SIMILAR POST-MARKETING PROGRAM AS IN EUROPE
  • FDA ANSWER IS EXPECTED TO THE REQUEST FOR PRIORITY REVIEW
  • FAST TRACK = ROLLING REVIEW

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