(Alliance News) - Amryt Pharma PLC on Tuesday said that US regulators gave fast track designation for the investigation of its AP101 drug to fight a rare, life-limiting skin condition.
Amryt said the US Food & Drug Administration recognised epidermolysis bullosa "is a serious disease" and there not yet any approved treatments for the condition.
Amryt explained: "The fast track programme is designed to accelerate the development and review of products such as AP101, which are intended to treat serious diseases and for which there is an unmet medical need. Fast track designation enables more frequent communication with the FDA and may allow for further benefit from FDA accelerated programmes such as priority review and/or rolling review."
Epidermolysis bullosa is a rare condition that results in easy blistering of skin, even with minor trauma.
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 epidermolysis bullosa, 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."
Shares in Amryt closed 0.2% higher at 130.80 pence each in London on Tuesday.
By Eric Cunha; ericcunha@alliancenews.com
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