Kedrion SpA announced European Medicines Agency orphan-drug designation for its investigational plasma-derived therapy to treat congenital aceruloplasminemia. The designation aims to facilitate clinical development and regulatory support in Europe for this ultra-rare iron‑metabolism disorder. Kedrion said the EMA status will support advancement toward clinical trials and potential commercialization. The company plans to leverage plasma-product manufacturing capabilities to develop a protein-replacement approach for patients lacking functional ceruloplasmin. Clarification: Aceruloplasminemia is a genetic disorder of iron handling leading to neurodegeneration and systemic iron overload; orphan designation grants incentives including regulatory assistance and market exclusivity potential.