Biopharmaceutical firm, Amryt Pharma (AMYT) , announced on Tuesday that it had received the green light from the U.S Food and Drug Administration for the investigation of their leading drug, AP101 (Oleogel-S10) as a Fast Track development program.
Specifically, the drug is being developed for the treatment of rare genetic condition, Epidermolysis Bullosa, a serious condition with unmet critical needs.
Having recognised this unmet need and the seriousness of the condition, the FDA have approved the Fast Track program as a means to accelerate the process development of AP101.
The decision made by the institution was further motivated by the fact that there is no existing FDA-approved treatments for the condition.
Fast Track will enable more frequent communication between Amryt and the FDA, with the biopharmaceutical firm gaining potential benefits from any further FDA programmes such as priority review and/or rolling reviews.
Commenting on the FDA's decision, Dr Joe Wiley, CEO of Amryt Pharma, stated "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."
He further added, “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."
Additionally, the FDA noted that Amryt has generated preliminary clinical data from an ongoing Phase 3 trial supporting continued study.
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