Damoctocog alfa pegol (1) – Jivi®

• Clinical trials
  • Study 13024 was an open-label, four-arm, partially randomised study comparing on-demand treatment with prophylactic treatment (three different treatment regimens) using damoctocog alfa pegol in previously treated adolescents (aged 12 to < 18 years) and adult male patients (aged ≥ 18 to 65 years) with severe haemophilia A.
  • The single-arm, non-randomised Phase I study 13401 investigated previously treated male patients with severe haemophilia A.

Patients aged 12 years and over with haemophilia A (congenital factor VIII deficiency)

• For the treatment and prophylaxis of bleeding in patients aged 12 years and over with haemophilia A (congenital factor VIII deficiency), the additional benefit compared with the appropriate comparator therapy is not proven.
• The pharmaceutical manufacturer has not provided any relevant data for the assessment of the additional benefit of damoctocog alfa pegol.
• The G-BA considers that, taken as a whole, the results presented are not sufficient to allow the derivation of patient-relevant effects regarding the additional benefit of damoctocog alfa pegol compared with the appropriate comparator therapy.
• On balance, therefore, no additional benefit is proven.

Courtesy translation only, please refer to the German original.