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Kiadis Pharma N.V.

Kiadis Pharma N.V.

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Publicatie datum 30 jun 2016 - 07:00
Statutaire naam Kiadis Pharma N.V.
Titel Kiadis Pharma’s Orphan Drug Designation for ATIR101™ further expanded to include treatment in a hematopoietic stem cell transplantation
Bericht Amsterdam, The Netherlands, June 30, 2016 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces that its lead product, ATIR101™, has been granted an expansion to its existing Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) to include treatment in a hematopoietic stem cell transplantation (HSCT). Kiadis Pharma was previously granted an ODD for ATIR101™ by both EMA and the United States Food and Drug Administration (FDA) for the prevention of Graft-versus-Host-Disease (GVHD) following an allogeneic HSCT. A further ODD was granted by the FDA for the prevention of Transplant Related Mortality following an allogeneic HSCT and a fourth ODD was granted by EMA for the treatment of acute myeloid leukemia (AML) following an allogeneic HSCT. This latter ODD has now been expanded by EMA to cover all uses of ATIR101™ as treatment in HSCT, regardless of the underlying disease.