The European Medicines Agency plans to seek external independent Epidermolysis Bullosa (EB) specific expertise and advice on assessing Amryt Pharma Plc's (NASDAQ:AMYT) Oleogel-S10.
- Oleogel-S10 is under development for cutaneous manifestations of Junctional and Dystrophic EB, a rare genetic skin disorder.
- The European Medicines Agency (EMA) review process for Oleogel-S10 in EB is ongoing, and Amryt has responded to outstanding questions.
- Related: Amryt's Skin Disorder Drug Application Review With FDA Extended By Three Months.
- Given the rarity of the disease without any approved therapies, the EMA has proposed that an Ad-Hoc Expert Group, comprised of both EB clinical experts and patients with EB, be consulted to provide external and independent EB-specific advice.
- The Committee for Medicinal Products for Human Use (CHMP) opinion is anticipated in March 2022.
- Price Action: AMYT shares are down 5.55% at $10.05 during the market session on the last check Friday.
