Voydeya (danicopan)
OrphanPRIMEAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- danicopan
- Company
- Alexion Europe SAS
- Status
- Authorised
- Therapeutic area
- Hemoglobinuria, Paroxysmal; Hemolysis
- CHMP opinion
- Thu 22 Feb 2024
- EU approval
- Fri 19 Apr 2024
- Designations
- Orphan, PRIME, Additional monitoring
- Application
- EMEA/H/C/005517
- ATC
- L04AJ09
- Official record
- www.ema.europa.eu
Indication
Voydeya is indicated as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia
Regulatory milestones
No milestones recorded in the last year.
Follow Voydeya
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.