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KOVALTRY (octocog alfa), antihaemophilic factor (factor VIII)

HAEMATOLOGY - New medicinal product
Opinions on drugs - Posted on Mar 29 2018

Reason for request

Inclusion

Substantial clinical benefit but no clinical benefit demonstrated by comparison with other coagulation factor VIII products in the treatment and prophylaxis of bleeding in patients with haemophilia A

 

  • KOVALTRY is a recombinant FVIII indicated in the treatment and prophylaxis of bleeding in patients with haemophilia A.
  • It is similar to KOGENATE, which it is intended to replace on the market. They both contain the same recombinant FVIII protein. 
  • In the course of clinical trials in previously treated patients, no case of FVIII inhibitor antibodies, thromboembolic event or anaphylactic reaction was reported.
  • In children with severe, previously untreated, haemophilia A, the interim data from the ongoing study report a risk of development of inhibitors at the upper limit of what is expected in this population. However, these data must be interpreted carefully given the small number evaluated and the interim nature of the results.

 


Actual benefit

Important

-


Improvement in actual benefit

V (absence)

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Therapeutic use

-

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