HYQVIA (human normal immunoglobulin) - Chronic inflammatory demyelinating neuropathy (CIDP)

The Committee deems that the clinical benefit of HYQVIA (human normal immunoglobulin) 100 mg/mL solution for infusion for subcutaneous use is substantial in immunomodulatory therapy in adults, children, and adolescents (0 to 18 years) with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) as maintenance therapy after stabilisation with IVIg. 

Considering: 

• the currently met medical need, due to the availability of numerous therapeutic alternatives;
• the results of the ADVANCE-1 pivotal study having demonstrated a superiority of HYQVIA (human normal immunoglobulin) versus placebo on the proportion of patients who experienced a relapse at the end of the 6-month double-blind period (mean difference: -21.8%; 95% CI 
  [-34.45; -7.94]; p<0.0045), but with methodological limitations, due, in particular, to a percentage 
  of missing data for the analysis of the primary endpoint, more frequent in the HYQVIA group 
  (human normal immunoglobulin) compared to the placebo group (9.7% versus 2.8%) and imputed as “absence of relapse”,
• the absence of clinical data in the paediatric population, for which the MA was extrapolated based on the clinical data observed in adults and in other diseases,
• the lack of comparative clinical efficacy data in relation to other human normal immunoglobulins administered intravenously or subcutaneously,
• the globally favourable safety profile marked by local adverse events (in particular, infusion site reactions) and general disorders (including headaches, pyrexia, diarrhoea),
• the presence of anti-rHuPH20 antibodies (titre ≥ 1/160) developing in a small number of patients included in the studies, and the transient detection of neutralising antibodies in two patients during the extension study (median follow-up of 33 months, with 56.5% of patients exposed for ≥ 2 years), meaning that it is not possible to eliminate the uncertainty relating to the long-term safety of the administration of recombinant human hyaluronidase, particularly with respect to fertility, 

the Committee deems that HYQVIA (human normal immunoglobulin) 100 mg/mL solution for subcutaneous infusion provides no clinical added value (CAV V) compared to the other human normal immunoglobulins administered intravenously or subcutaneously.