CHMP recommends approval of Voncento (CSL Behring) for Haemophilia A/Von Willebrand disease

The Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Voncento (Human coagulation factor VIII), from CSL Behring, to be used for the prevention and treatment of bleeding in patients with Haemophilia A and Von Willebrand disease.

The recommendation is based on the assessment of two main studies, one study investigating the effects of Voncento in 81 patients with Haemophilia A , and one investigating the effects of Voncento in 22 patients with Von Willebrand disease. Voncento was effective in preventing the occurrence of bleeding events in patients with severe Haemophilia A and in stopping bleeding in patients with severe Von Willebrand disease. When bleeding events did occur in Haemophilia A patients on prophylaxis, Voncento was effective in treating these events. Voncento was also effective in the prevention and treatment of bleeding in surgery. Side effects were generally mild to moderate.