Hansa Medical receives orphan drug status for Ides in Europe
Release Date: 27-Jan-2017
Handa Medical, a pharmaceutical company announced that European medicines Agency has granted orphan drug designation to its leading product candidate, 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.
European orphan designation is granted to drugs that are intended for the treatment of life-threatening or chronically debilitating rare diseases for which no therapeutic options either exist or are satisfactory. Rare diseases are those defined as having a prevalence of less than 5 in 10,000 in Europe. The designation provides sponsors with development and commercial incentives, including 10 years of market exclusivity, designated product specific consultation by EMA, and certain exemptions from, or reductions in, regulatory fees.
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