02 August 2016
CLINUVEL prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP)
- FDA requirement for combination therapy model replicating clinical studies protocol in vitiligo fulfilled
- Safety of the combination therapy confirms observations in clinical trials CUV102 and CUV103
- CLINUVEL will request a guidance meeting with the FDA to discuss the upcoming vitiligo trial in North America
- Safety data add to the New Drug Application package to be submitted to the FDA for erythropoietic protoporphyria (EPP)
- Global experts agree on the lack of current satisfactory treatment in vitiligo
CLINUVEL Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that that it has fulfilled the FDA requirement to demonstrate safety in a pre-clinical model prior to progressing further with the clinical development of the combination therapy of its drug SCENESSE® (afamelanotide 16mg) and narrowband UVB (NB-UVB) light in the pigmentation disorder vitiligo.