Jun 24 2022 European Commission Approves Filsuvez for DEB and JEB
Yesterday, the European Commission approved Amryt Pharma’s Filsuvez®, a gel treatment for partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older. The approval was supported by data from the Phase III EASE trial, the largest ever global trial conducted in EB patients, performed across 58 sites in 28 countries. Read the full Amryt Pharma press release.
Today, Amryt announced its plans to proceed to the Formal Dispute Resolution pathway in the U.S. Food & Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) by which New Drug Application (NDA) applicants can seek to resolve scientific and / or medical disputes that cannot be resolved at the division level. This follows a Complete Response Letter in February 2022 where the FDA communicated that the Oleogel-S10 (Filsuvez) application could not be approved in its present form. See the full press release from Amryt Pharma.
We welcome this first approved treatment for EB in any market, as we relentlessly pursue our goal of effective treatments, and ultimately a cure for all types of EB.