The U.S. Food and Drug Administration (FDA) notified Biopure Corporation that it will complete its review and act on the company's biologic license application (BLA) for Hemopure (hemoglobin glutamer - 250 bovine) by August 29, 2003. Biopure has applied to market Hemopure in the United States for the treatment of acutely anemic patients undergoing orthopedic surgery and for the elimination or reduction of red blood cell (RBC) transfusions.
Biopure submitted its BLA on July 31, 2002. Under FDA performance goals in the Prescription Drug User Fee Act (PDUFA III), the agency has up to 10 months from the submission date to review and act on the BLA, making the original action due date June 1, 2003. As part of the normal review process, Biopure has responded to FDA questions regarding the application. The agency has classified the latest responses submitted in mid-May 2003 as additional analyses of previously submitted data, which under FDA standard operating procedures automatically provides the agency up to three months beyond the original action due date to review the data. This type of action is not unusual-the last 11 standard BLAs accepted for review by the FDA have undergone a 13-month review.
"We're very pleased with the FDA's progress in reviewing our application," said Biopure President and CEO Thomas A. Moore. "We continue to work closely with the agency toward a final decision that will allow us to make Hemopure available as an alternative to red blood cell transfusion. We're also continuing our preparations to roll out the product to leading orthopedic surgery centers following approval."
The BLA includes clinical data from a multinational, RBC-controlled Phase III orthopedic surgery trial and from a similar non-U.S. Phase III general non-cardiac surgery trial. It also contains an integrated database of all 22 Hemopure clinical trials, encompassing more than 1400 total subjects of which more than 800 received Hemopure.
Hemopure is an oxygen therapeutic, or drug, consisting of chemically stabilized bovine hemoglobin formulated in a balanced salt solution. This stabilized hemoglobin circulates directly in plasma (the fluid part of blood) when infused, increasing oxygen diffusion to the body's tissues. The product is compatible with all blood types, can be stored for three years without refrigeration or special handling, and is purified through patented and proprietary techniques that are validated to remove potential contaminants, including infectious agents such as bacteria, viruses and transmissible spongiform encephalopathy (TSE) agents.
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.