The pivotal EPP trials

The randomized evidence behind the approval

Afamelanotide reached approval on the strength of two randomized, placebo-controlled trials in EPP, backed by an early signal from a tiny case series. This unit walks through that evidence and what the numbers actually mean.

It also takes the limitations seriously: the two trials measured sunlight time differently, and any tanning drug is hard to blind. Honest reading means holding the strong result and the real caveats together.