Clinuvel is currently testing SCENESSE® (afamelanotide) in clinical trials in Europe, Australia and the United States, under the auspices of the relevant regulatory authorities. The company filed a marketing authorisation approval with the European Medicines Agency in February 2012.
US Food and Drug Administration (FDA)
Clinuvel commenced a clinical trial program for SCENESSE® in the US in mid 2009, following the approval of an Investigational New Drug (IND) application in January 2009. The FDA allowed a Phase II trial for erythropoietic protoporphyria (EPP) to commence in March 2010 and a Phase II trial for vitiligo to commence in March 2011. In March 2012 Clinuvel and the FDA agreed in principle to a Phase III study for EPP, expected to commence in May 2012.
Orphan Drug Designations
SCENESSE® has been granted two Orphan Drug Designations (ODDs) by the FDA’s Office of Orphan Products Development, for erythropoietic protoporphyria (EPP) in July 2008 and for solar urticaria (SU) in December 2009.
- FDA grants Clinuvel orphan-drug designation 29/7/2008
- FDA allows IND status for Clinuvel's SCENESSE® 29/1/2009
- FDA grants Clinuvel an additional orphan drug designation 17/12/2009
- FDA allows US clinical trials of SCENESSE® in EPP 30/03/2010
- FDA provides positive guidance on Clinuvel's EPP program 9/11/2010
- FDA allows Clinuvel's innovative vitiligo trial 3/3/2011
- Orphan Product Designation - more about orphan products from the FDA website
- US Office of Orphan Products Development (OOPD) website
European Medicines Agency (EMA)
Clinuvel has run a clinical trial program with SCENESSE® in Europe since 2005, with over 40 individual approvals received from 11 EU member states’ regulatory bodies to run trials of the drug. In February 2012 Clinuvel filed SCENESSE® for marketing authorisation with the European Medicines Agency for EPP.
Phase III clinical trials of SCENESSE® have been approved and completed in: France, Germany, Italy, Netherlands, Sweden and the UK.
Phase II clinical trials of SCENESSE® have been approved and have completed or are are underway in: Austria, Belgium, France, Germany, Italy and the UK.
Orphan Drug Designations
SCENESSE® has been granted Orphan Drug Designations (ODDs) by the EMA’s Committee for Orphan Medical Products (COMP) for erythropoietic protoporphyria (EPP) and congenital erythropoietic porphyria (CEP) in March 2008 and for solar urticaria (SU) in June 2009.
- EMEA grants Clinuvel two orphan drug designations 12/3/2008
- [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 new orphan drug designation 18/6/2009
- Public summary of positive opinion for orphan designation of SCENESSE® for the treatment of solar urticaria – EMA Announcement
- Clinuvel announces strategic focus of final regulatory program 10/2/2010
- Clinuvel files European marketing authorisation application for SCENESSE® (afamelanotide) 6/2/2012
Italian Medicines Agency (AIFA)
In May 2010, the Italian Medicines Agency (AIFA) allowed SCENESSE® to be prescribed to patients with erythropoietic protoporphyria (EPP) in Italy under Law 648/96, prior to the drug's formal approval for marketing authorisation in any jurisdiction. For more information, see the company's announcement.
Australian Therapeutic Goods Administration (TGA)
In November 2010 SCENESSE® was granted an Orphan Drug Designation by the TGA for the treatment of erythropoietic porphyrias; you can read the relevant announcement here.
US FDA & Australia's TGA
The FDA and TGA, as well as other regulatory agencies, exchange information in relation to drug development, in particular manufacturing processes. Reports of inspection from the FDA undergo a desk-top audit prior to clearance of the site.
Currently a pilot project is being evaluated by the FDA, EMA and TGA to collaborate on GMP inspection activities. This project is primarily focused with reducing the duplication of inspections internationally and on developing consistency amongst the regulatory authorities.