Complete Response Letter for Oleogel-S10 for Epidermolysis Bullosa.
Amryt has announced it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Oleogel-S10, for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB), a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma for which there are no approved treatment options.
The FDA communicated that it had completed its review of the application and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns.
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