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Amryt Pharma: US Food & Drug Administration gives phase III drug fast-track status

AP101 is being developed for epidermolysis bullosa (EB), where tissue blisters to the touch

Amryt Pharma PLC -
The FDA designation is granted to drug candidates that treat serious illnesses where there is an unmet medical need

Amryt Pharma PLC’s (LON:AMYT) drug for a rare and serious skin condition has been given fast-track status by the US regulator.

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.

Quick facts: Amryt Pharma PLC

Price: 204 GBX

AIM:AMYT
Market: AIM
Market Cap: £331.97 m
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