Riociguat (4) – Adempas®

• Clinical trials
  • The PATENT-CHILD study presented in the dossier is a single-arm study investigating treatment with riociguat, in combination with endothelin receptor antagonists, in children and adolescents aged 6 to < 18 years.

Paediatric patients weighing ≥ 50 kg to < 18 years of age with pulmonary arterial hypertension (PAH)

• For paediatric patients weighing ≥ 50 kg and aged < 18 years with pulmonary arterial hypertension (PAH), the additional benefit of riociguat, in combination with endothelin receptor antagonists, compared with the appropriate comparator therapy is not proven.
• An additional benefit of riociguat, in combination with endothelin receptor antagonists, compared with the appropriate comparator therapy is not proven.
• The pharmaceutical manufacturer has not provided any data for the assessment of the additional benefit of riociguat, in combination with endothelin receptor antagonists, compared with the appropriate comparator therapy.
• Due to the lack of comparison with the appropriate comparator therapy, this study is not taken into account for the present benefit assessment.

Courtesy translation only, please refer to the German original.