FDA Rejects Amryt Pharma's Oleogel-S10 Application For Skin Blistering Disorder

Amryt Pharma Plc 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.

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