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Phase 3
Development Phase
1
Upcoming Catalysts
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Historical Events
1
Regulatory Approvals
0 competitors in Paroxysmal Nocturnal Hemoglobinuria (PNH)
View Full LandscapeTarget Indication
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Clinical Trial
NCT04820530Last updated: 1/16/2026
No patent data available. Pre-approval drugs may not have Orange Book listings.
Fabhalta
Paroxysmal nocturnal haemoglobinuria Fabhalta is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Complement 3 glomerulopathy Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated (see section 5.1).