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EMA approval · 2024-03-22

First oral monotherapy for patients with paroxysmal nocturnal haemoglobinuria

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Summary

EMA has recommended EU marketing authorization for Fabhalta (iptacopan), an oral monotherapy for adults with paroxysmal nocturnal haemoglobinuria and haemolytic…

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Diseases / indications

Drugs mentioned

  • FABHALTA (IPTACOPAN)

Snippet

EMA has recommended granting a marketing authorisation in the European Union (EU) for Fabhalta (iptacopan), an oral treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.