Kedrion SpA secured European orphan drug designation for its investigational plasma‑derived therapy for congenital aceruloplasminemia, the company announced. The EMA’s orphan tag applies to a condition characterized by iron accumulation and neurodegeneration, and it grants regulatory incentives including market exclusivity and protocol support. Kedrion said it will advance the program toward clinical development in Europe. For companies in the rare‑disease space, orphan designation lowers regulatory and commercial hurdles and can accelerate patient access strategies when clinical proof is obtained.
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