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Clinuvel and FDA discuss EPP indication and regulatory pathways for SCENESSE®

Clinuvel and FDA discuss EPP indication and regulatory pathways for SCENESSE®

The attached document discusses the latest news from FDA and Clinuvel:
Type C meeting provides guidance for follow up and further discussions between FDA and Clinuvel.
Clinuvel Pharmaceuticals Limited (ASX: CUV; ADR:CLVLY; XETRA:DAX) today announced that on September 30 it met in Silver Spring, USA, with the US Food and Drug Administration's (FDA's) Division for Dermatology and Dental Products (DDDP) and representatives of the Center of Drug Evaluation and Research (CDER). The objective of the meeting was to discuss the US regulatory review of SCENESSE® (afamelanotide 16mg) to be made available to American erythropoietic protoporphyria (EPP) patients. In 2014 SCENESSE® was granted marketing authorisation by the European Medicines Agency as a prophylactic photoprotective drug for adult EPP patients.
The DDDP stated that it was seeking a regulatory pathway to make SCENESSE® available in the US, and the regulatory avenue of Accelerated Approval was suggested, pending FDA's review, analyses and further discussions on available photoprovocation and data on quality of life in EPP patients.
A discussion was held on the drug's benefits to patients who had received SCENESSE®. Expert European and US porphyria clinicians were invited to share their experience in the treatment of EPP patients and the use of SCENESSE® in their patients. Further discussions will be held with the DDDP following the review of photoprovocation and quality of life data.



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