Bayer's Kogenate gets EU OK for use in surgery

Bayer Healthcare AG, a division of Germany's Bayer, says that its product Kogenate Bayer (recombinant antihemophilic factor, formulated with sucrose) has received European Medicines Agency (EMEA) approval for use as a continuous infusion treatment for hemophilia A patients undergoing major surgery. The firm added that continuous infusion of the product is likely to be more convenient than administration via bolus injection.

Bayer said that the drug can lower the risk of Factor VIII concentrations dropping below the therapeutic hemostatic level, which reduces the chance of bleeding complications. The firm added that a recent clinical study had confirmed that continuous infusion of the agent resulted in the level of hemostasis being classed as "excellent" (87%) or "good" (13%) in patients undergoing surgical procedures.

In addition, the results showed that bleeding events and blood loss were within the expected ranges, and the use of the product was well-tolerated. Bayer added that there had been no unexpected safety concerns, and no drug-related treatment emergent adverse events. Also, none of the study participants developed de novo antibodies to the agent.