Bayer granted approval for Kogenate

Bayer HealthCare has announced it has been granted continuous infusion indication by the European Commission for the entire of the EU for its Kogenate product line.

Kogenate Bayer, its recombinant factor VIII product, used to treat hemophilia A, has received EU approval for continuous infusion in hemophilia A patients who are undergoing major surgery.

The company lauded the decision as “a major advancement in hemophilia care”, claiming that continuous infusion has been seen to lead to “excellent” patient outcomes. In addition, it affords surgeons increased confidence in the therapy of these patients, Dr Georg Lemm, director of global clinical development Kogenate at Bayer HealthCare, asserted.

In addition, continuous infusion with Kogenate Bayer may be more convenient for operating surgeons than using a bolus injection.

“Surgery in patients with hemophilia is challenging because hemostatic factor levels must be regularly monitored and controlled to reduce bleeding,” noted Dr Lemm.

“In contrast to bolus infusion, continuous infusion of factor VIII can lower the risk that factor levels will drop below the therapeutic hemostatic level, resulting in less bleeding complications,” he added.

Kogenate is an antihemophilic factor formulated with sucrose indicated for the treatment of hemophilia A.