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news.Kiadis Pharma, an oncology focused pharmaceutical development company, has announced that its lead product Atir has received orphan drug designation from the European Medicines Agency for the prevention of acute graft versus host disease following an allogeneic bone marrow transplantation.
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The European Medicines Agency’s orphan drug designation is reserved for new therapies being developed to treat life-threatening or chronically debilitating diseases or conditions that are relatively rare in the EU and for which no satisfactory therapy is available.
The orphan drug designation provides for incentives to support research and development, exemption from user fees and a 10-year period of market exclusivity in the EU after product approval.
Manja Bouman, CEO of Kiadis Pharma, said: “Following the orphan drug designation granted by the FDA for our lead product Atir, this is another important milestone in the development of Atir as a novel approach which may enable a safe and potentially life-saving mismatched bone marrow transplantation as a treatment option for end-stage blood cancer patients.”