Regulatory Status

Clinuvel is currently testing or aims to shortly commence testing of afamelanotide in clinical trials in Europe, Australia and the United States, under the auspices of the relevant regulatory authorities. Further information may be found via the following links.

US Food and Drug Administration (FDA) - two different Orphan Designations for afamelanotide ODD granted July 2008 (EPP) FDA grants Clinuvel orphan-drug designation - Clinuvel ASX Announcement Orphan Product Designation - more about orphan products from the FDA website US Office of Orphan Products Development (OOPD) website ODD granted December 2009 (SU) FDA grants Clinuvel an additional orphan drug designation - Clinuvel ASX Announcement
Australian Therapeutic Goods Administration (TGA)
Swissmedic - ODD granted April 2008 Swissmedic grants Clinuvel Orphan Drug Status for CUV1647 - Clinuvel ASX Announcement
European Medicines Agency (EMA) - two different Orphan Designations for afamelanotide ODD granted March 2008 (EPP) [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone for the treatment of erythropoietic protoporphyria - EMA Announcement [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone for the treatment of congenital erythropoietic porphyria - EMA Announcement EMA grants Clinuvel two orphan drug designations - Clinuvel ASX Announcement ODD granted June 18 2009 (SU) EMA grants Clinuvel new orphan drug designation - Clinuvel ASX Announcement EMA COMP issues summary of positive opinion for orphan designation for the treatment of solar urticaria - EMA announcement Human medicines - Orphan medicinal products - more about Orphan medicines on the EMA website