Clinuvel Pharmaceuticals Grabs FDA’s First Approval for Rare Skin Disorder
The FDA granted Clinuvel Pharmaceuticals approval for Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of skin damage as a result of rare metabolic disorder.
The FDA granted the approval based on the results of two parallel group clinical trials. One trial showed that over 180 days, patients taking the medication were able to spend on average 64 total hours in direct sunlight, compared to 41 hours on placebo.
The second trial showed that over 270 days spent outdoors, patients receiving Scenesse spent six hours in daylight without pain, as opposed to 45 minutes for patients receiving placebo.
Scenesse was previously granted orphan drug designation.