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Amryt Due For Oral Explanation At EMA For Epidermolysis Bullosa Gel Filsuvez

Capmatinib Developer May Also Make Its Case Before The CHMP

 
• By Vibha Sharma

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.

Filsuvez contains dry extract of bark from birch trees • Source: Alamy

The sponsors of two investigational products were due to appear before the European Medicines Agency this week to explain why their drugs that are in the final stages of regulatory review should be recommended for pan-EU marketing approval.

Amryt Pharmaceuticals was to make its case at an oral explanation meeting with the EMA for Filsuvez, its birch bark extract-based topical gel for epidermolysis bullosa that was rejected by US regulators last month

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