Hansa Medical AB (STO:HNSA), a biopharmaceutical company focused on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, on Tuesday provided an update following the company's regulatory interactions with the European Medical Agency (EMA) and the US Food and Drug Administration (FDA) for imlifidase in kidney transplantation.

According to the company, the meetings with the EMA and FDA were productive and both agencies provided positive feedback on the data generated on imlifidase to date and acknowledged the high unmet medical need of highly sensitised patients who currently can't access kidney transplantation.

Also, in Europe, the company continues to expect to file a Marketing Authorisation Application with the EMA this quarter.

This dialogue with the FDA to determine the path forward for regulatory approval in the US will continue in a subsequent meeting in the coming months per the agency's request for additional information regarding imlifidase treatment in the context of the new US Kidney Allocation System (KAS).

Hansa Medical will provide updated guidance regarding expected timeline for a potential BLA filing after this meeting has taken place. Its highest priority is getting imlifidase to market to enable lifesaving kidney transplants for highly sensitised patients, who currently can't receive this standard of care treatment.