ELOCTA (efmoroctocog alfa), factor VIII
HAEMATOLOGY - New medicinal product
Opinions on drugs - Posted on May 25 2016
Reason for request
No clinical benefit demonstrated by comparison with other coagulation factor VIII products in the treatment and prophylaxis of bleeding in patients with haemophilia A
- ELOCTA has Marketing Authorisation in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). It is indicated in all age groups.
- It is a recombinant FVIII with an extended half-life
- In the absence of direct comparison, the studies do not allow a conclusion about its possible benefit compared with other available FVIIIs in reducing bleeding or frequency of injections, especially in young children.
Clinical Added Value
|no clinical added value||
Évaluation des médicaments