dm+d

Unassigned

Refrigerated Storage

Idefirix  Hansa Biopharma AB

Hansa Biopharma AB
Idefirix 
Powder for concentrate for solution for infusion

Contact Hansa Biopharma AB in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

7 March 2022
London MI Service

New Medicines

Idefirix Transplant rejection prevention in HLA-sensitised patients

Information

Idefirix
New molecular entity
Hansa Biopharma AB
Hansa Biopharma AB

Development and Regulatory status

Launched
Approved (Licensed)
Phase II Clinical Trials
December 2020
Dec 20Available in the UK. Price £135,000 x 1 vial [7,8].
Aug 20Granted conditional approval in EU [6].
Jun 20Recommended for EU approval by CHMP - the full indication is "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." It is proposed that the medicine be prescribed by physicians experienced in the management of immunosuppressive therapy and of sensitised renal transplant patients [5].
Oct 19Hansa Biopharma announce that the regulatory review process for imlifidase is progressing as planned. The company expect to receive an opinion from the committee for medical products of European Medicines Agency in the first half of 2020 [4].
Mar 19Granted PRIME status by EMA May 2017 on basis of data from four independent Phase II studies (NCT02224820, NCT02426684, NCT02475551 and NCT02790437) [2].
Mar 19EMA accept MAA for approval of imlifidase as a treatment to enable kidney transplantation in highly sensitised patients [1].

Category

Immunoglobulin G-degrading enzyme derived from Streptococcus pyogenes
Approximately one third of dialysis patients are sensitised to human leukocyte antigens (HLA), which increases the risk of acute antibody mediated rejection (AMR) and hyper acute graft failure [3].
Transplant rejection prevention in HLA-sensitised patients
Intravenous

Further information

Yes

Evidence based evaluations