Hansa Medical receives orphan drug status for Ides in Europe
Handa Medical, a pharmaceutical company announced that European medicines Agency has granted orphan drug designation to IdeS.
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.
For Orphan Drug Clinical Insight Reports Contact: firstname.lastname@example.org
Need custom market research solution? We can help you with that too.
Kuick Research is a market research and analytics company that provides targeted information for critical decisions at business, product and
service levels. We are quick, predictive and known by the recommendations we have made in the past. Our result-oriented research methodology offers
understanding of multiple issues in a short period of time and gives us the capability to keep you full with loads of practical ideas.