Imlifidase

Unassigned

New Medicines

Transplant rejection prevention in HLA-sensitised patients

Information

New molecular entity
HansaMedical
HansaMedical

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase II Clinical Trials

Mar 19: Granted PRIME status by EMA May 2017 on basis of data from four independent Phase II studies (NCT02224820, NCT02426684, NCT02475551 and NCT02790437) [2].


Mar 19: EMA 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