The FDA on Tuesday announced the approval of Clinuvel Pharmaceuticals' Scenesse (afamelanotide), a subcutaneous implant to boost pain-free light exposure in adults with a history of phototoxic reactions due to erythropoietic protoporphyria. Julie Beitz, director of the FDA's Center for Drug Evaluation and Research Office of Drug Evaluation III, noted that "prior to today's approval, there were no FDA-approved treatments to help erythropoietic protoporphyria patients increase their light exposure."
The decision was backed by results from two parallel-group clinical trials in which patients with erythropoietic protoporphyria received Scenesse or a placebo form of the implant subcutaneously every two months. Clinuvel previously reported data from the Phase III CUV039 trial , which involved 93 patients who were followed for 180 days, showing that the median total number of hours spent in direct sunlight on days with no pain was 64 hours for patients receiving Scenesse, versus 41 hours for placebo.
Meanwhile, the second trial enrolled 74 patients who were followed for 270 days. The median total number of hours spent outdoors on days with no pain, for which most of the day was spent in direct sunlight, was six hours for patients receiving Scenesse and 0.75 hours for placebo.
According to the FDA, Scenesse is an MC1-R agonist that increases the production of eumelanin in the skin regardless of exposure to sunlight or artificial light sources. In June, the agency extended  its review of Clinuvel's submission  by three months.
The therapy, which was authorised  by EU regulators in 2014 for preventing phototoxicity in adults with erythropoietic protoporphyria, generated AUD 25.8 million ($17.4 million) in revenue last year.