Kedrion SpA announced that the European Medicines Agency (EMA) granted orphan drug designation to its investigational plasma‑derived treatment for congenital aceruloplasminemia. The designation recognizes the therapy's potential to treat a rare, genetically defined iron‑metabolism disorder and provides regulatory incentives intended to accelerate clinical development in Europe. Kedrion plans to advance the program toward clinical testing; orphan status can facilitate protocol advice, fee reductions and market exclusivity if approved. The move signals continued industry interest in replacing absent proteins via plasma‑derived or biologic therapies for rare metabolic diseases. Clinicians and rare‑disease drug developers should watch Kedrion’s planned development timeline and any EMA interactions that clarify required evidence for benefit in this ultra‑rare population.