Clinuvel has announced that its photoprotective drug Afamelanotide has been granted an orphan drug designation (ODD) by the FDA for the management of solar urticaria (SU). This is the second ODD granted to Afamelanotide by the FDA since its awarded Afamelanotide its ODD status for the treatment of erythropoietic porphyrias.
Philippe Wolgen, CEO of Clinuvel, said: “This additional FDA award for Afamelanotide boosts our confidence in the choices we have made for this development program, for which we identified that our drug would provide the optimum medical utility and benefit for patients affected by UV and light. After more than a decade of development, a critical factor to the commercial success of the drug will hinge on market protection and exclusivity. Today’s FDA verdict provides us precisely this.”
Earlier in July 2009, Clinuvel announced positive results from a pilot Phase II study of SU, showing SU patients’ tolerance to light (UV and other wavelengths) increased following the administration of Afamelanotide. Afamelanotide was granted orphan medicinal product status by the European Medicines Agency for SU in June 2009.
Clinuvel is preparing final Phase III trials in SU to start in the spring in the northern hemisphere in 2010.