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KOGENATE Bayer (octocog alfa), recombinant human coagulation factor VIII

Opinions on drugs - Posted on Feb 29 2016

Reason for request


In previously untreated patients with a severe haemophilia A, last-line treatment to be used in case of a functional or life-threatening emergency and in the absence of the other available FVIII.


  • HELIXATE NexGen and KOGENATE Bayer, identical medicinal products, have Marketing Authorisation in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
  • The efficacy of replacement therapy for haemophilia A using FVIII concentrates may be compromised by the development of inhibitors of FVIII activity, the most serious complication of the treatment.
  • KOGENATE Bayer/HELIXATE NexGen is likely to increase the risk of inhibitors development  compared to other recombinant FVIII in patients with severe, previously untreated, haemophilia A.

Actual benefit



Improvement in actual benefit

V (absence)


Therapeutic use


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