Biopure’s blood substitute under FDA review

OCT 2–CAMBRIDGE, MA–Biopure Corp. says its biologic license application for its blood substitute, Hemopure, has been accepted for review by the U.S. Food and Drug Administration (FDA).

The acceptance is based on the agency’s determination that the application is adequate to permit a substantive and meaningful review.

On July 31, 2002, Biopure submitted an electronic application to the FDA seeking regulatory clearance to market Hemopure in the United States for the treatment of acute anemia in adult patients undergoing orthopedic surgery, and for eliminating or reducing the need for red blood cells in these patients.

The application was based on two Phase III clinical trials and an integrated database of all 22 Hemopure clinical trials, including data for more than 1400 total subjects of which more than 800 received Hemopure.

“This is the fourth regulatory milestone for our technology we’ve passed that no competitor has achieved,” says Biopure’s President and CEO Thomas A. Moore. “Approvals for our veterinary product in the United States and European Union, the approval of Hemopure in South Africa for human use and now FDA acceptance of our application for review in the United States.”

Moore adds that while the FDA will decide whether the our application is approvable, the acceptance is affirms the clinical data Biopure has amassed.

“This latest ‘first’ for Biopure should help support our efforts to establish new business relationships and product indications. We will continue to work closely with the FDA on this review while also preparing other international filings,” he says.


Easily post a comment below using your Linkedin, Twitter, Google or Facebook account. Comments won't automatically be posted to your social media accounts unless you select to share.