Orphan Drug Status
In September 2015, U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to IdeS for the prevention of antibody mediated organ rejection in solid organ transplant patients. In December 2016 the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) issued a positive opinion on Hansa Medical’s application for Orphan Drug Designation of recombinant IdeS for the prevention of graft rejection following solid organ transplantation
Approximately 30 percent of the patients on the waiting lists for kidney, heart, lung and pancreas, equivalent to approximately 35 000 patients in the US, are sensitized to Human Leukocyte Antigen (HLA). HLA sensitization is a risk factor in transplantation and a significant part of the sensitized patients are rarely considered for transplantation due to the increased risk of antibody mediated organ rejection. Hansa Medical currently conducts Phase II trials with candidate drug IdeS for the prevention of antibody mediated organ rejection in kidney transplant patients.