Amryt Pharma Says European Commission Oks Filsuvez For Dystrophic And Junctional EB

RTTNews | 1138 hari yang lalu
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Amryt Pharma Says European Commission Oks Filsuvez For Dystrophic And Junctional EB

(RTTNews) - Biopharmaceutical company Amryt Pharma plc (AMYT) announced the European Commission (EC) approval of Filsuvez in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.

EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market.

The centralized marketing authorization will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez in the EU provides a regulatory core dossier which may form the basis for future regulatory submissions in LATAM and the Middle East.

The EC approval of Filsuvez is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.

Teg: AMYT
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Biopharmaceutical company Amryt Pharma plc (AMYT) announced Friday that the company plans to submit a Formal Dispute Resolution Request (FDRR) for the company's New Drug Application (NDA) for Oleogel-S10 (Filsuvez), for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).
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PERINGATAN RISIKO TINGGI: Perdagangan pertukaran mata wang asing mempunyai risiko tinggi yang mungkin tidak sesuai untuk semua jenis pelabur. Leveraj menimbulkan risiko dan kerugian tambahan. Sebelum anda memutuskan untuk berdagang pertukaran mata wang asing, pertimbangkan dengan teliti objektif pelaburan, tahap pengalaman dan toleransi risiko anda. Anda berkemungkinan kehilangan sebahagian atau semua pelaburan awal anda. Jangan melaburkan wang yang anda tidak mampu untuk kehilangan. Didik diri anda tentang risiko yang berkaitan dengan perdagangan pertukaran asing, dan dapatkan nasihat daripada penasihat bebas kewangan atau cukai jika anda mempunyai sebarang pertanyaan mengenainya. Semua data dan maklumat yang disediakan adalah semata-mata untuk tujuan maklumat, dan bukan bertujuan untuk tujuan perdagangan atau nasihat. Prestasi masa lalu tidak semestinya menunjukkan hasil masa depan.