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.
Clinical Added Value
|no clinical added value||
Évaluation des médicaments