Swissmedic time-limited market approval in for Idefirix in kidney transplantation
Swedish rare disease specialist Hansa Biopharma (STO: HNSA) today revealed that the Swiss Agency for Therapeutic Products (Swissmedic) has granted time-limited market approval for Idefirix (imlifidase) for adult patients with a positive cross-match against an accessible organ from a deceased donor.
The use of Idefirix in Switzerland is reserved for patients with a low probability of being transplanted under the current national kidney allocation system. The drug was approved by the European Commission in 2020.
" We want to ensure access to Idefirix for highly sensitized patients worldwide who are awaiting a potentially vital kidney transplant and are now pleased that, in addition to the market approvals already received in the EU, UK and Israel, we have also received approval in Switzerland," says Søren Tulstrup, chief executive and president of Hansa Biopharma.
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