Idefirix (imlifidase)
OrphanPRIMEConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- imlifidase
- Company
- SERB SA
- Status
- Authorised
- Therapeutic area
- Desensitization, Immunologic; Kidney Transplantation
- CHMP opinion
- Thu 25 Jun 2020
- EU approval
- Tue 25 Aug 2020
- Designations
- Orphan, PRIME, Conditional, Additional monitoring
- Application
- EMEA/H/C/004849
- ATC
- L04AA
- Official record
- www.ema.europa.eu
Indication
Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
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.