Hansa Biopharma has announces that the Swiss Agency for Therapeutic Products (Swissmedic) has granted temporary marketing authorization for Idefirix in adult patients with a positive crossmatch against an available organ from a diseased donor.
The use of Idefirix in Switzerland is reserved for patients with a low probability of being transplanted within the framework of the current national kidney allocation system.
“We are committed to ensuring access to Idefirix for highly sensitized patients across the globe awaiting a potentially lifesaving kidney transplant and are pleased that we have now received approval in Switzerland in addition to the already received marketing authorizations in the EU, the U.K. and Israel,” says Søren Tulstrup, President and CEO, Hansa Biopharma.
Supported by data from four different Phase 2 open-label, single arm studies
Idefirix is the first and only medicine authorized for desensitization of highly sensitized patients prior to kidney transplantation, enabling these patients to better access a life-changing kidney transplantation from a deceased donor.
The Marketing Authorization Application (MAA) in Switzerland was supported by data from four different Phase 2 open-label, single arm studies evaluating imlifidase in sensitized patients awaiting kidney transplantation.
Photo of Søren Tulstrup: Hansa Biopharma