Northfield Laboratories Inc announced that the US Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for PolyHeme, the company's investigative human haemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available. In addition, FDA has designated the submission for Priority Review, with a review goal date of April 30, 2009.
"Filing of our BLA for PolyHeme with Priority Review is a key milestone for Northfield," said Steven A Gould, chairman and chief executive officer. "We are now one step closer to delivering a potential life-saving therapy to patients who need transfusion in situations when blood is not available."
Northfield announced that it had submitted the BLA for PolyHeme on October 29, 2008, based on its comprehensive development programme, including data from its Multicenter phase-III randomized, double-blind trial involving 720 trauma patients. Findings from this study were presented at the American College of Surgeons, appeared online in the Journal of the American College of Surgeons in November, and are scheduled for publication in the print edition in January 2009.
Northfield Laboratories is a leader in developing a haemoglobin-based oxygen-carrying red blood cell substitute.