Posted by Michael Wonder on 16 Sep 2020
EMA approves label update for Hyqvia (human normal immunoglobulin 10% and recombinant human hyaluronidase), expanding its use to a broader group of patients with secondary immunodeficiencies
15 September 2020 - Takeda today announced that the EMA has approved a label update for Hyqvia (human normal immunoglobulin 10% and recombinant human hyaluronidase) broadening its use and making it the first and only facilitated subcutaneous immunoglobulin replacement therapy in adults, adolescents and children with an expanded range of secondary immunodeficiencies.
With the update, Hyqvia is now indicated for use as a replacement therapy in adults, children and adolescents (0-18 years) with secondary immunodeficiencies who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven scientific antibody failure or serum IgG level of <4 g/L.
