AP101 is being developed for epidermolysis bullosa (EB), where tissue blisters to the touch.
Currently undergoing a phase III clinical trial, the treatment will now be on an accelerated development and review pathway under the Food & Drug Administration’s protocol.
Fast-track designation also allows for more frequent communication with the watchdog, while AP101 may benefit from a priority and/or rolling review.
It is granted to drug candidates that treat serious illnesses where there is an unmet medical need.
Amryt chief executive Joe Wiley said: “Receiving a fast-track designation from the FDA represents another significant step in the progress of our lead development asset – AP101 – as a potential treatment for the wound related complications of EB, a rare and life limiting condition.
“This designation, alongside the other significant efforts of our team globally, drives our continued progress and brings us closer to realising our vision of becoming a global leader in rare and orphan diseases.”
Fast-track status is another landmark for the group, which recently completed a transformational acquisition.