HYQVIA (normal human immunoglobulin co-administered with recombinant human hya-luronidase) - Immunoglobulin

The Committee deems that the clinical benefit of HYQVIA (normal human immunoglobulin co-administered with recombinant human hyaluronidase) 100 mg/ml, for subcutaneous use, remains substantial in the MA indications.

For adults

In view of:

• the currently met medical need, on account of the presence of numerous available therapeutic alternatives;
• the lack of new clinical efficacy data;
• an overall positive safety profile of HYQVIA marked by adverse events, of which the most frequent have been infections (in particular sinusitis, bronchitis, upper respiratory tract infection) and general injection-related disorders (in particular fever, injection site pain) based on the latest post-authorisation safety studies (European study 161302, US study 161406), and severe acute bacterial infections only occurring in PID patients (FIGARO observational study);
• the presence of anti-rHuPH20 antibodies with a titre ≥ 160 (positive test) occurring in a small number of patients included in the studies, with an overall positive anti-rHuPH20 antibody binding test estimated between 0.04 and 0.317 cases per patient-year;
• the set-up of a prospective pregnancy registry (PASS study 161301) including only 9 pregnant women of whom 7 received HYQVIA replacement therapy, in which the findings showed a negative anti-rHuPH20 antibody binding test for the 4 patients who were tested;

the Committee deems that HYQVIA (normal human immunoglobulin co-administered with recombinant human hyaluronidase) provides no clinical added value (CAV V) in relation to other normal human immunoglobulins administered intravenously or subcutaneously.

For children and adolescents (aged 0 to 18 years)

In view of:

• the partially met medical need, on account of the presence of numerous available therapeutic alternatives;
• the lack of comparative clinical efficacy data in relation to other immunoglobulins administered intravenously or subcutaneously;
• an overall positive safety profile of HYQVIA marked by local adverse events (in particular pain and infusion site pruritus) and general injection-related disorders (in particular fatigue, fever and headaches), based on the latest post-authorisation safety (European study 161504 and U.S. study 161406) and efficacy (U.S. Study 161503) studies;
• the lack of follow-up in particular in safety in 5 infants exposed in utero to HYQVIA, and followed up for the first two years of their lives (PASS study 161301)
• the presence of anti-rHuPH20 antibodies with a titre ≥ 160 (positive test) occurring in one patient (U.S. study 161503) and with no reports of neutralising antibodies detection during all of the additional 2-year follow-up visits, without however eliminating uncertainty in respect of the effects of concomitant hyaluronidase administration on fertility;

the Committee deems that HYQVIA (normal human immunoglobulin co-administered with recombinant human hyaluronidase) provides no clinical added value (CAV V) in relation to the therapeutic alternatives.