Northfield Labs to Shut Down After FDA Rejects Proposed Blood Substitute

Northfield Laboratories, the Illinois-based maker of a human red blood cell substitute, plans to close its doors after the Food and Drug Administration refused to approve the product.

Performing the necessary additional clinical research and development of PolyHeme before re-submitting the product to the FDA would be too expensive, Northfield said. Also, there is too much uncertainty about whether the agency would approve the drug even then, the company said.

Northfield said it is unlikely that it could raise enough money to support more development of PolyHeme.

In April 2009, the FDA said it lacked sufficient information to approve the blood substitute.

PolyHeme is a human hemoglobin-based temporary oxygen-carrying red blood cell substitute that was being developed by Northfield for the treatment of life-threatening blood loss when an oxygen-carrying fluid is required and red blood cells are not available.

The chemical is a solution of chemically modified human hemoglobin which replenishes lost blood volume along with hemoglobin levels and is designed for rapid, massive infusion.

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