The pivotal EPP trials

The randomized evidence behind the approval

Afamelanotide reached US approval on one adequate and well-controlled trial, CUV039, with two further trials treated as supportive. The two registration trials were published together in the New England Journal of Medicine, and this unit walks through that evidence and what the numbers actually mean.

It also takes the limitations seriously: the two published trials measured sunlight time differently, and the published report says the visible increase in skin pigment partially unblinded the trial. Honest reading means holding the strong result and the real caveats together.