Hansa Medical receives FDA Orphan Drug Designation for IdeS

14 Sep, 2015, 14:30

Regulatory information

Hansa Medical today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to IdeS for the prevention of antibody mediated organ rejection in solid organ transplant patients. More information about the ODD has been posted on www.fda.com

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.

“We are pleased to receive orphan designation for IdeS in the US as HLA sensitization constitutes a significant barrier for transplantation for thousands of patients annually. We believe that IdeS has the potential to enable transplantation for these patients ” states Göran Arvidson, CEO at Hansa Medical AB.

The information in this press release is disclosed pursuant to the Securities Markets Act or the Financial Instruments Trading Act. The information was released for public disclosure on September 14, 2015 at 14.30 CET.

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