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Regulatory status

Imlifidase Regulatory status

The European Commission has conditionally authorized imlifidase, marketed as IDEFIRIX®, for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.1

1. European Medicines Agency. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/IDEFIRIX. [Access May 2024]

Orphan designation

The European Medicines Agency (EMA) granted imlifidase orphan drug designation for the treatment of anti-glomerular basement membrane (anti-GBM) antibody disease (July 2018) and for the prevention of graft rejection following solid organ transplantation (January 2017). Upon IDEFIRIX® EMA conditional approval, a ten-year orphan drug market exclusivity was also granted.

In the US, the Food and Drug Administration (FDA) granted imlifidase orphan drug designation for the prevention of Antibody-mediated organ rejection (AMR) in solid organ transplant patients (September 2015); Guillain-Barré syndrome (GBS) (February 2018); and anti-GBM antibody disease, also known as Goodpasture’s disease (July 2018). An orphan drug designation qualifies sponsors for incentives including a potential seven years of market exclusivity after approval.