2017 Announcements
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