19 May 2017 - Hansa Medical announced today that EMA has granted access to its Priority Medicines (PRIME) scheme for IdeS; Hansa Medical's lead candidate intended for desensitisation of highly sensitised kidney patients thus making them eligible for transplantation by inactivation of anti-HLA IgG antibodies.

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-sensitised patients, who received IdeS immediately before kidney transplantation. IdeS was shown to be effective in reducing donor specific antibodies to levels allowing lifesaving kidney transplantation.

The clinical multi-centre study Highdes (NCT02790437) is currently recruiting patients in the U.S. and Europe that have either failed on previous attempts of desensitisation or are considered to be too difficult to desensitise with currently available methods. The aims are to complete recruitment of approximately 20 patients during 2017, submit a biologics license application to the FDA in 2018 in order to get marketing authorisation to commercialise IdeS in the U.S. and file marketing authorisation application to the EMA for marketing authorisation of IdeS in the European market.

Read Hansa Medical press release