Fabhalta (iptacopan)
- Region
- 🇪🇺 EU
- Active substance
- iptacopan
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Hemoglobinuria, Paroxysmal
- CHMP opinion
- Thu 21 Mar 2024
- EU approval
- Fri 17 May 2024
- Designations
- Orphan, PRIME, Additional monitoring
- Application
- EMEA/H/C/005764
- ATC
- L04A
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.