Jan 15, 2019
“We have had very productive meetings with the EMA and FDA, during which both agencies provided positive feedback on the data generated on imlifidase to date and acknowledged the high unmet medical need of highly sensitized patients who currently can’t access kidney transplantation,” said Søren Tulstrup, President and CEO of Hansa Medical AB.
“In Europe, we continue to expect to file a Marketing Authorization Application with the EMA this quarter. The dialogue with the FDA to determine the path forward for regulatory approval in the U.S. 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 U.S. Kidney Allocation System (KAS). We will provide updated guidance regarding expected timeline for a potential BLA filing after this meeting has taken place. Our highest priority is getting imlifidase to market to enable lifesaving kidney transplants for highly sensitized patients, who currently can’t receive this standard of care treatment,” continued Mr. Tulstrup.
The U.S. Kidney Allocation System was updated in 2014 in order to increase equity in allocation, reduce kidney discard rates and reduce organ/recipient longevity mismatches. While the KAS has improved the possibility for highly sensitized patients to receive a kidney transplant, thousands of highly sensitized patients remain unable to be successfully matched.
In September 2018, Hansa successfully completed two Phase 2 clinical studies evaluating imlifidase for kidney transplantation in highly sensitized patients, with imlifidase enabling transplantation in all 35 patients. Imlifidase met all primary and secondary endpoints in each study. Imlifidase has received Fast Track designation from the FDA and has been selected for Priority Medicines (PRIME) by the EMA. Imlifidase has received Orphan Drug Designation from the EMA and FDA.
This is information that Hansa Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CET on January 15, 2019.