IdeS selected for EMA Priority Medicines (PRIME) scheme
Göran Arvidson, President and CEO of Hansa Medical, said: “The granting of PRIME access by the EMA allows us to continue to accelerate the development of IdeS. We believe IdeS could be a potentially transformative treatment option for those patients in need of lifesaving kidney transplantation. We would like to thank the EMA for their support and we look forward to working with them to advance this important new drug towards submission of a Market Authorization Application (MAA) for EU marketing authorization.”
The PRIME designation for IdeS was granted on the basis of data from four independent Phase II studies in the U.S. and Sweden (ClinicalTrials.gov Identifiers NCT02224820, NCT02426684, NCT02475551 and NCT02790437), the request included data from 30 HLA-sensitized patients, who received IdeS immediately before kidney transplantation. IdeS was shown to be effective in reducing donor specific antibodies (DSAs) to levels allowing lifesaving kidney transplantation.
The clinical multicenter study Highdes (NCT02790437) is currently recruiting patients in the U.S. and Europe that have either failed on previous attempts of desensitization or are considered to be too difficult to desensitize with currently available methods. The aims are to complete recruitment of approximately 20 patients during 2017, submit a Biologics License Application (BLA) to the FDA in 2018 in order to get marketing authorization to commercialize IdeS in the U.S. and file Marketing Authorization Application (MAA) at the European Medicines Agency (EMA) for marketing authorization of IdeS in the European market.
The information in this press release is disclosed pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the contact person stated below on May 19, 2017 at 14.00 CEST.