Aspaveli (pegcetacoplan)
- Region
- 🇪🇺 EU
- Active substance
- pegcetacoplan
- Company
- Swedish Orphan Biovitrum AB (publ)
- Status
- Authorised
- Therapeutic area
- Hemoglobinuria, Paroxysmal
- CHMP opinion
- Thu 16 Sep 2021
- EU approval
- Mon 13 Dec 2021
- Designations
- Orphan
- Application
- EMEA/H/C/005553
- ATC
- L04AJ03
- Official record
- www.ema.europa.eu
Indication
Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Aspaveli is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Syfovre Refused · Apellis Europe B.V.
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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.