FDA Grants Priority Review to Amryt’s EB Drug

The U.S. Food and Drug Administration granted Priority Review designation to Amryt Pharma’s New Drug Application for Oleogel-S10 for the treatment of the rare connective tissue disorder epidermolysis bullosa.

Photo: Joe Wiley, CEO of Amryt Pharma

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.

The FDA grants priority review 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. 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 is expected to act on the company’s application by November 30, 2021.

The FDA previously granted Fast Track designation and Rare Pediatric Disease designation to Oleogel-S10.

“If approved, Oleogel-S10 could potentially be an important treatment option for patients suffering from EB, a serious and debilitating disease for which there are currently no approved treatments and our launch plans for Oleogel-S10 are well advanced,” said Joe Wiley, CEO of Amryt Pharma.

Author: Rare Daily Staff