Amryt Pharma Advances Regulatory Applications for Filsuvez

Amryt Pharma Advances Regulatory Applications for Filsuvez

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Amryt Pharma Advances Regulatory Applications for Filsuvez

Amryt Pharma has completed its rolling submission of an application to the U.S. Food and Drug Administration seeking the approval of Filsuvez (Oleogel-S10), a topical gel to heal skin wounds in people with junctional (JEB) and dystrophic epidermolysis bullosa (DEB). The new drug application (NDA) includes a request for priority review, which can quicken the review process to six months following submission acceptance. The rolling submission of the NDA began June 29. In parallel, the European Medicines Agency (EMA) has validated an application…

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