Amryt Pharma Plc (NASDAQ:AMYT) has received a Complete Response Letter (CRL) from the FDA regarding Oleogel-S10 application for cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).
- EB is a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma.
- The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB.
- Amryt intends to discuss the nature of the data required to address the concerns with the FDA.
- Also See: Amryt Shares Fall After Oleogel-S10 EMA Regulatory Update.
- Joe Wiley, CEO of Amryt Pharma, commented: "We are extremely disappointed by this decision, and we remain committed to our goal of bringing Oleogel-S10 to patients...The EASE study was the largest randomized clinical trial ever conducted in this disease and the first Phase 3 study to meet its primary endpoint."
- Price Action: AMYT shares are down 17.6% at $6.70 during the market session on the last check Monday.
