KOGENATE Bayer (octocog alfa), recombinant human coagulation factor VIII
HAEMATOLOGY - Focus
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.
Improvement in actual benefit
Évaluation des médicaments