Biopure Corporation announced that the U.S. Food and Drug Administration (FDA) has completed its review of the company's biologic license application (BLA) for Hemopure [hemoglobin glutamer - 250 (bovine)] and issued a letter requesting additional information. The letter focuses primarily on clarification of clinical and preclinical data and includes some comments on labeling. It does not request additional clinical trials. Biopure has applied to market Hemopure in the United States for the treatment of acutely anemic adult patients undergoing orthopedic surgery and for the elimination or reduction of red blood cell transfusions in these patients.
With 30 days remaining in the original BLA review cycle, the issuance of the letter has suspended the FDA review clock until Biopure submits a complete response.
"We're encouraged that the FDA has finished its review and provided comprehensive feedback in advance of the formal action due date. By maintaining thirty days on the review clock, the FDA is encouraging us to work with them to complete the approval process as quickly as possible," said Biopure President and CEO Thomas A. Moore. "We'll work with the Agency to address the remaining questions and will provide our answers as expeditiously as possible."
Anemia is a shortage of RBCs in the body that can create an oxygen deficit and lead to cell damage, organ dysfunction or, in severe cases, death. Acute anemia, usually caused by blood loss, is the primary indication for a RBC transfusion. In 1999, approximately 1.4 million RBC units were transfused in 500,000 high blood loss orthopedic surgical procedures. These statistics are expected to increase as the population ages.
Hemopure is an oxygen therapeutic, or drug, consisting of chemically stabilized bovine hemoglobin formulated in a balanced salt solution. This stabilized, acellular hemoglobin circulates directly in plasma (the fluid part of blood) when administered intravenously, increasing oxygen delivery and diffusion. The product is compatible with all blood types, is stable for three years at room temperature (2 degrees to 30 degrees Celsius), and is purified through patented and proprietary techniques that are validated to remove potential contaminants.