Italian Medicines Agency Approves NerPharMa to Manufacture CTI’s Drug Pixantrone in European Union
News Jun 15, 2010
Cell Therapeutics, Inc. (CTI) has announced that the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS for the production of CTI's drug candidate pixantrone.
CTI is in the process of preparing a Marketing Authorization Application (MAA) in the European Union for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
"We are pleased that the AIFA has approved the NerPharMa facility to manufacture pixantrone as we continue to receive positive feedback on the clinical trial results from leading clinicians in Europe and make progress in the submission of the MAA in Europe," said Craig W. Philips, President of CTI.