CPX-351 is the Celator’s proprietary ‘liposomal combination of cytarabine and daunorubicin’ injection, indicated to treat acute myeloid leukemia (AML).
The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA), the company said.
The US Food & Drug Administration (FDA) has already granted orphan drug designation to CPX-351 (Cytarabine:Daunorubicin) Liposome Injection for the treatment of acute AML.
Celator Pharmaceuticals CEO Scott Jackson said receiving orphan status is a key milestone in their strategy to develop CPX-351 in this patient population which urgently needs therapeutic advances.