24 June 2022 - Amryt today announces that the company plans to submit a formal dispute resolution request for the company’s new drug application for Oleogel-S10 (Filsuvez), for the treatment of the cutaneous manifestations of dystrophic and junctional epidermolysis rullosa, a rare, genetic skin disease characterised by extremely fragile skin that blisters and tears from minor friction or trauma and for which there are no approved treatment options in the US.

Amryt recently had a Type A meeting with the US FDA to discuss the issues raised in the complete response letter received in February 2022 relating to Amryt’s new drug application for Oleogel-S10. 

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