Orphan Drug Designation for Pixantrone in Europe

20 December 2009 (Last Updated December 20th, 2009 18:30)

Cell Therapeutics (CTI) has announced that the European Medicines Agency (EMEA) has granted orphan drug designation for pixantrone, which is used to treat around 80% of aggressive non-Hodgkin's lymphoma cases. CTI expects to file a Marketing Authorization Application (MAA) for approval

Cell Therapeutics (CTI) has announced that the European Medicines Agency (EMEA) has granted orphan drug designation for pixantrone, which is used to treat around 80% of aggressive non-Hodgkin's lymphoma cases.

CTI expects to file a Marketing Authorization Application (MAA) for approval of pixantrone in Europe in mid-2010, which would offer ten-year market exclusivity if it is approved.

Achieving orphan drug designation is intended to promote availability of drugs used to treat life-threatening or chronically debilitating conditions. The benefits of the designation are numerous and include regulatory assistance, reduced regulatory fees and assistance with clinical trials.

CTI president Craig Philips said that there is clear unmet medical need for patients with diffuse large B-cell lymphoma.

"We will continue to move our application forward in Europe expeditiously as we prepare for potential commercial launch of pixantrone in the US," Phillips said.

Pixantrone is a novel topoisomerase II inhibitor that utilises an aza-anthracenedione molecular structure, which differentiates it from anthracyclines and other related chemotherapy agents.

Pixantrone is a fast-track designated product in the US and is in review for approval by the Food and Drug Administration, with a Prescription Drug User Fee Act date of 23 April 2010.