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HELIXATE NexGen (octocog alfa), recombinant human coagulation factor VIII
HAEMATOLOGY - Focus
Opinions on drugs -
Posted on
Jan 05 2016
Reason for request
Re-assessment of the actual benefit
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 Benefit
| Substantial |
- |
Therapeutic use
|
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