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FDA grants priority review for NDA for Oleogel-S10 to treat Epidermolysis Bullosa.- Amryt

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Last updated:24th Sep 2021
Published:4th Jun 2021
Amryt announces that the FDA has granted Priority Review for Amryt’s New Drug Application (“NDA”) for Oleogel-S10 for the treatment of Epidermolysis Bullosa (“EB”). Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.

 Priority Review is granted by the FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. In general, the FDA’s Priority Review designation accelerates the review time from ten months to a goal of six months from the date of acceptance of the filing. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target action date for the Oleogel-S10 NDA of November 30, 2021.

Condition: Epidermolysis Bullosa
Type: drug