Amryt Earns Wings For Butterfly Skin Drug In Europe
CHMP Recommends Approval Of Filsuvez
CEO Joe Wiley has said the backing of the EMA's advisory committee for its epidermolysis bullosa gel represents "the most significant milestone in Amryt’s history" and is a massive boost for the Dublin-headquartered group after getting a complete response letter in the US a couple of months ago.
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As the American Academy of Dermatology meeting ends in Boston, Scrip looks at some of the key data presented at the congress covering the latest advances in the hot area of atopic dermatitis, alopecia and butterfly skin.
Amryt Pharmaceuticals is set to appear before the European Medicines Agency to explain why its treatment for patients with epidermolysis bullosa merits EU-wide approval. The drug was recently rejected in the US.
A regulatory filing for Vyjuvek in the US is targeted for the first half of 2022 following the positive results of a Phase III trial, positioning Krystal for its first commercial launch.