Simoctocog alfa (1) – Nuwiq®

• Clinical trials
  • To enable a direct comparison of simoctocog alfa with octocog alfa, the pharmaceutical manufacturer has submitted data from the GENA-01 and GENA-09 trials.
  • The first part (RCT part) of the GENA-01 and GENA-09 studies consists of a randomised, controlled, open-label crossoverphase, each involving 22 enrolled patients, to compare the pharmacokinetic parameters of Simoctocog alfa with those of the appropriate comparator therapy selected by the pharmaceutical manufacturer, Kogenate® (active ingredient (INN): Octocog alfa).

Haemophilia patients requiring factor VIII replacement

• There is no additional benefit compared with the appropriate comparator therapy for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital Factor VIII deficiency).
• The additional benefit compared with the appropriate comparator therapy is therefore not proven.
• Neither of the two pharmacokinetic studies is suitable for assessing the additional benefit of Simoctocog alfa compared with the G-BA’s appropriate comparator therapy, due to the short study duration (single dose).
• Consequently, there are no relevant direct comparative studies available for assessing the additional benefit of simoctocog alfa compared with the appropriate comparator therapy.
• In summary, the studies presented under ‘Further investigations’ are, on the whole, unsuitable for assessing the additional benefit of simoctocog alfa.
• The pharmaceutical manufacturer has not provided any comparative data that can be sufficiently interpreted with regard to patient-relevant endpoints.
• The G-BA considers the results presented, taken as a whole, to be unsuitable for deriving patient-relevant effects regarding the benefits and harms of simoctocog alfa compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.