HYQVIA, (Human normal immunoglobulin)

IMMUNOLOGY - New medicinal product

Opinions on drugs - Posted on Oct 02 2015

Inclusion

HYQVIA has Marketing Authorisation in replacement therapy for adults with primary or secondary immunodeficiency in myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinaemia and recurrent infections
The combination of human normal immunoglobulin G with recombinant human hyaluronidase permits HYQVIA to be administered in a single subcutaneous injection every 3 or 4 weeks.
It makes it possible to obtain an annual rate of acute serious bacterial infections of 0.025, below the limit of 1 predefined by health agencies.
The advantage of HYQVIA, which permits monthly SC administration at a single site is not reflected by an improvement in quality of life relative to IGIV administered monthly at a single site or IGSC administered weekly at several sites.
Given the lack of direct comparative data versus other immunoglobulins and the lack of data in secondary immunodeficiencies and Ig treatment initiation in primary immunodeficiencies, the choice of one Ig over another cannot be determined.

Substantial

no clinical added value

Therapeutic use

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