NUWIQ (simoctocog alfa), human coagulation factor (factor VIII)

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

• NUWIQ has Marketing Authorisation in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). This factor VIII is produced in host cells of human origin (human embryonic kidney (HEK) 293 F cells).
• In phase III trials with this product no patients developed anti-factor VIII inhibitors, which is a major complication of factor VIII replacement therapy.
• The safety profile appears to be similar in children and adults.