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Biopure applies for U.K. marketing authorization of Hemopure
By Elaine Rigoli
Tampa, Fla., July 11 - Biopure Corp. said it has submitted a marketing authorization application to the U.K Medicines and Healthcare products Regulatory Agency (MHRA) for Hemopure, the company's universally compatible, room-temperature-stable oxygen therapeutic.
Biopure is seeking MHRA authorization to market this new biologic medicine in the United Kingdom for the treatment of acutely anemic adult orthopedic surgery patients younger than 80 years old.
The filing is based on preclinical studies and clinical trials of Hemopure, including new analyses of existing data from a 688-patient phase 3 orthopedic surgery trial conducted in the United States, South Africa, Europe and Canada and from a 160-patient phase 3 general non-cardiac surgery trial conducted in South Africa and Europe.
The application also contains an integrated database of all completed trials, including data for about 1,500 total subjects, of which more than 800 were administered Hemopure, according to a news release.
In addition, the marketing authorization application describes the post-approval clinical experience with Hemopure in South Africa, where the product is indicated for the treatment of adult surgical patients who are acutely anemic, the release said.
Anemia is a deficiency of red blood cells in the bloodstream caused by blood loss or other disorders, which can compromise the body's oxygen-carrying capacity and in severe cases lead to cell damage, organ dysfunction or death.
Cambridge, Mass.-based Biopure develops oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues.
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