UK Commission Letter on Blood Substitute Cites Safety, Efficacy Concerns

Biopure’s effort to get UK approval for its blood-substitute candidate Hemopure hit a snag as regulators said major issues remain involving safety, quality, clinical efficacy, reliability of data monitoring and auditing of clinical trials.

The Commission on Human Medicines noted the lack of data in trauma patients as a concern for the potential off-label use of Hemopure [hemoglobin glutamer — 250 (bovine)]. However, the agency invited Biopure to discuss these issues with a Medicines and Healthcare products Regulatory Agency (MHRA) team of medical, statistical and pharmaceutical reviewers.

Hemopure’s application was accepted for review in September 2006, and the MHRA issued its preliminary opinion a few months later. The company had requested an indication for treatment of acutely anemic adult orthopedic surgery patients younger than 80. In its response to the preliminary opinion, submitted last November, Biopure changed the product’s indication to the treatment of acute anemia following orthopedic surgery blood loss when blood is not readily available or is not an option.

While the commission’s most recent letter said Biopure’s November response reassured the commission on several questions, it added that major pharmacological and clinical issues were not yet or only partially resolved. The company noted the commission has not advised it to withdraw its application.