Northfield Laboratories, founded in 1985, is a leading developer of an oxygen-carrying blood substitute. Its product, PolyHeme, is the only blood substitute undergoing clinical trials that has been tested at large enough dosages to be considered a substitute for acute blood loss in trauma and surgical settings. As a result of the process used to manufacture the blood substitute, essentially a solution of polymerized hemoglobin, PolyHeme has a longer shelf life than blood, requires no cross matching and does not transmit disease.
Northfield Laboratories Inc. reported that it received comments from the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) on its Biologics License Application (BLA), submitted August 2001. CBER indicated that they are seeking additional information before accepting the application for filing and issued a Refusal-to-File letter to the company.
Advertisement" Refusals for first-time submissions are common,'' said Richard DeWoskin, chief executive officer of Northfield Laboratories Inc. " We are encouraged by the constructive information provided in CBER's initial response, and believe that while the next few months will be busy, there is good reason to expect that modifications resulting from this feedback will help us to progress to the next stage of the application process. The regulatory review will be a multi-stage process. There now will be a period of several weeks during which we will interact with CBER to clarify and come to fully understand the issues in question." said Richard.
The company said the letter included both questions and comments about Northfield's blood substitute, PolyHeme, from CBER. Management said it will quickly begin the process of addressing these issues.