Idefirix

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imlifidase

Authorised
This medicine is authorised for use in the European Union.

Overview

Idefirix is a medicine used to prevent the body from rejecting a newly transplanted kidney.

Idefirix is used before transplantation in adults who have antibodies against the donor kidney and are considered ’highly sensitised’ based on a positive crossmatch test. It should be reserved for patients who are unlikely to obtain a transplant under the available kidney allocation system.

Graft organ rejection following solid organ transplantation is rare, and Idefirix was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 January 2017.

Idefirix contains the active substance imlifidase.

This EPAR was last updated on 28/08/2020

Authorisation details

Product details
Name
Idefirix
Agency product number
EMEA/H/C/004849
Active substance
Imlifidase
International non-proprietary name (INN) or common name
imlifidase
Therapeutic area (MeSH)
  • Desensitization, Immunologic
  • Kidney Transplantation
Anatomical therapeutic chemical (ATC) code
L04AA
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Hansa Biopharma AB
Date of issue of marketing authorisation valid throughout the European Union
25/08/2020
Contact address

P.O. Box 785
SE-22007
Lund
Sweden

Product information

25/08/2020 Idefirix - EMEA/H/C/004849 -

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic 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.

Assessment history

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