Italian medicines agency OKs NerPharMa facility to make Cell Therapeutics' pixantrone in EU

The Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of US firm Cell Therapeutic's drug candidate pixantrone.

CT is in the process of preparing a Marketing Authorization Application in the European Union for pixantrone, proposed trade name Pixuvri, to treat relapsed or refractory aggressive non-Hodgkin's lymphoma.

"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 Philips, president of CT. The company previously stated that it expects to file for EU approval of the drug in the third quarter of this year.