EMA
approval
· 2024-03-22
First oral monotherapy for patients with paroxysmal nocturnal haemoglobinuria
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
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.