Gadopiclenol (2) – Elucirem®

• Clinical trials
  • The pharmaceutical manufacturer did not submit any comparative studies for the assessment of the additional benefit of gadopiclenol.
  • In addition, the two single-arm studies GDX-44-015 and GDX-44-014 were submitted, but were not used to establish additional benefit.
  • The GDX-44-015 study is a non-randomised, single-arm study in children from birth to 23 months who were scheduled to undergo routine gadolinium-enhanced MRI of any body region (including the CNS).
  • In addition, the pharmaceutical company has provided further details on the paediatric, non-randomised, single-arm cohort from study GDX-44-014, which included children and adolescents from birth up to 18 years of age with an indication for contrast-enhanced MRI of the CNS or the body, is also presented by the pharmaceutical manufacturer.

Children from birth up to the age of < 2 years for whom contrast-enhanced magnetic resonance imaging is indicated to improve the detection and visualisation of pathologies involving a disruption of the blood-brain barrier and/or vascular abnormalities in areas of the body

• For children from birth up to the age of < 2 years for whom contrast-enhanced magnetic resonance imaging is indicated to improve the detection and visualisation of pathologies involving a disruption of the blood-brain barrier and/or vascular anomalies in specific areas of the body, the additional benefit is not proven.
• The studies GDX-44-015 and GDX-44-014 do not allow for a comparison with the appropriate comparator therapy and, due to their study design, are not suitable for mapping the diagnostictherapeutic pathway with gadopiclenol compared with the diagnostic-therapeutic pathway of the active ingredients used in the appropriate comparator therapy.
• In its dossier, the pharmaceutical manufacturer does not take into account the possibility of a concordance question and, accordingly, does not carry out any information gathering that would be suitable for ensuring that all studies relevant to answering a concordance question are identified.
• Overall, no data have been submitted that fulfil the necessary requirements for the assessment of additional benefit.
• On balance, therefore, the additional benefit of gadopiclenol over the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.