Vyjuvek (beremagene geperpavec)
OrphanPRIMEATMPAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- beremagene geperpavec
- Company
- Krystal Biotech Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Epidermolysis Bullosa Dystrophica
- CHMP opinion
- Thu 27 Feb 2025
- EU approval
- Wed 23 Apr 2025
- Designations
- Orphan, PRIME, ATMP, Additional monitoring
- Application
- EMEA/H/C/006330
- ATC
- D03AX16
- Official record
- www.ema.europa.eu
Indication
Vyjuvek is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth
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.