Benzinga | Jun 3, 2021 08:07AM EDT

Amryt Pharma's Oleogel-S10 Application Gets FDA Priority Review Tag for Skin Blistering Disorder

* The FDA has granted priority review status to Amryt Pharma's (NASDAQ:AMYT) marketing application seeking approval for Oleogel-S10 to treat Epidermolysis Bullosa (EB).

* Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB, a rare genetic skin disorder characterized by blistering lesions on the skin and mucous membranes.

* 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 target action date of November 30.

* Oleogel-S10 had previously received Fast Track Designation and Rare Pediatric Disease Designation from the FDA. If the NDA for Oleogel-S10 is approved, the company will apply for a priority review voucher.

* "Confirmation of a target PDUFA date of November 30 keeps us on track for potential approval this year," said CEO Joe Wiley.

* Yesterday, the FDA accepted for review the company's Oleogel-S10 marketing application. The agency had informed that notification of any filing review issues, including priority review determination and target action date, would be provided by June 12.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: AMYT shares closed at $11.65 on Wednesday.