Benefits of Kogenate/Helixate NexGen outweigh risks, says EMA unit

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the anticoagulants Kogenate (recombinant Factor VIII) from Germany’s Bayer (BAYN: DE) and Helixate NexGen from CSL Behring, a unit of Australia's CSL Ltd (ASX: CSL), coming up with a favorable opinion.

The PRAC concluded that current evidence did not confirm an increased risk of developing antibodies (factor VIII inhibitors) against these medicines when compared with other factor VIII products in previously untreated patients with the bleeding disorder haemophilia A.

Therefore, the benefits from taking Kogenate Bayer and Helixate NexGen, which are known as second generation factor VIII products, continue to outweigh the risks. Factor VIII is needed for blood to clot normally and is lacking in patients with haemophilia A.