The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product HyQvia, 100 mg/ml, solution for infusion for subcutaneous use intended for:
Replacement therapy in adults ( greater than 18 years ) in primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, IgG subclass deficiencies with recurrent infections;
Replacement therapy in adults ( greater than 18 years ) in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
The active substance of HyQvia is human normal Immunoglobulin, an immune sera and immunoglobulins: immunoglobulins, normal human.
Human normal immunoglobulin contains mainly immunoglobulin G ( IgG ) with a broad spectrum of opsonising and neutralizing antibodies against infectious agents. Human normal immunoglobulin contains the IgG present in the normal population. It is usually prepared from pooled human plasma from not fewer than 1,000 donations. It has a distribution of IgG subclasses closely proportional to that in native human plasma. Adequate doses of human normal Immunoglobulin may restore abnormally low IgG levels to the normal range.
The benefits with HyQvia are its ability to lower the rate of validated, acute, serious bacterial infections per year. HyQvia is administered subcutaneously with an initial infusion of an excipient recombinant human hyaluronidase which facilitates the dispersion and absorption of IG 10% every 3 to 4 weeks.
The most common side effects are local reactions ( discomfort / pain, erythema, swelling/oedema, and pruritus ), fatigue and headache. ( Xagena )
Source: European Medicines Agency, 2013