Visit to the FDA

** Update: EPP patients met with FDA. ** August 2, 2013 was a memorable day for the APF members, who met at the FDA to explain Erythropoietic Protoporphyria (EPP) and asked that the FDA approve Afamelanotide/SCENESSE for EPP.  Most of the attendees had participated in the Phase II and Phase III clinical trials and were eager to elaborate on their positive experience on the drug.  We sincerely thank Florence Rollwagen, Diana Ijames, Mike Kenworthy, Steve Ferry, Pierre Mouledoux, Mike Ferry, and Andrew Turell, who spoke eloquently about EPP and its effect on their lives.  Each person presented common threads and unique aspects of dealing with EPP, as well as their experience with the treatment.  It was poignant to hear how a daily life of pain, isolation and anxiety was changed when they were given the implant.  Johnathan Turell, and Kristen Wheeden spoke about being parents of a loved one with EPP and shared the family dynamics that occur with the disease.  



We also thank Desiree Lyon Howe, who arranged the meeting with the FDA and gave an overview of the APF efforts for the Phase II and Phase III clinical trials, as well as discussed the Porphyria Research Consortium of porphyria experts and their research on Afamelanotide.  Our appreciation goes to the co-chairs of the Porphyria Research Consortium, Drs Robert Desnick and Karl Anderson, who explained the disease and spoke on their research on Afamelanotide and their views on the beneficial effect it had on the research volunteers. 

Each of the presentations to the FDA representatives was outstanding.  We hope they will assist the FDA in understanding the importance of approving a treatment for EPP, specifically approval of Afamelanotide as soon as possible.


“Remember…..Research is the key to your cure!”