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.

butterfly
• Source: Shutterstock

Rejected by US regulators in February, Amryt Pharma's butterfly skin therapy Filsuvez has been recommended in Europe to the delight of the Irish firm and patients with the rare and devastating hereditary disorder.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Filsuvez, which is also known as Oleogel-S10, for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients six months and older. There is currently no approved treatment for the rare genetic condition where skin can tear at the slightest touch and Amryt made its case at an oral explanation meeting with the EMA last month

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