New drug for secondary immunodeficiency (SID)! Takeda HyQiva has been approved by the European Union to update the label: for adults, adolescents, children!

September 16, 2020 // -- Takeda recently announced that the European Commission (EC) has approved The HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human Hyalurase) label update to expand its use, making it the first and only easy-to-use subsurface immunoglobulin replacement therapy for the treatment of a wider group of patients with secondary immunodeficiency (SID), including adults, adolescents and children.
With the latest label updates, HyQvia is now suitable as an alternative therapy for SID adults, children and adolescents (0-18 years of age) patients with severe or recurrent infections, ineffective antimicrobial therapy, proven specific antibody failure (PSAF) or serum IgG levels of 4g/L.
, HyQvia was approved as an alternative therapy for adults, children and adolescents (0-18 years of age) with impaired primary immunodeficiency syndrome.
the label update is based on a wealth of evidence from clinical trials that under-the-skin immunoglobulin injections can reduce infection rates in SID patients.
, the EMA has updated its product characteristics summary (SMPC) for intravenous human normal immunoglobulin (IVIg) with effect in 2019.
efficacy and safety of HyQvia were also evaluated in patients with secondary immunodeficiency of blood malignancies in a retrospective single-center study.
of HyQvia remains the same after the label is expanded.
HyQvia is a two-bottle package consisting of a bottle of human normal immunoglobulin (IGI, 10%) and a bottle of recombinant human hyalurase (rHuPH20) for subdernation (SC) dosing.
hyalurase is beneficial for the dispersion and absorption of immunoglobulin (IGI) under the skin.
HyQvia is allowed to be administered subskin every 3 or 4 weeks as an alternative to intravenous or more frequent SC administers.
primary immunodeficiency (PID) is a group of more than 400 genetic disorders, some of which have a missing or abnormal immune system.
estimated that 6 million people worldwide may have PID, but only 650,000 have been diagnosed.
secondary immunodeficiency (SID) occurs in patients with weakened immune systems due to disease or treatment interventions.
both conditions can lead to impaired or inadequate antibodies and a risk of repeated serious infections and hospitalization.
estimates that SID is 30 times more common than PID.
increased use of treatments for B cells may also lead to the prevalence of SID.
SID is usually initially treated with preventive antibiotics.
immunoglobulin (IG) has been shown to be effective in reducing infection in patients who have failed or been banned from prophylactin.
() Original origin: European Medicines Agency approved Labels Update for HYQVIA® (Human Normal Immunoglobulin 10% and Recombinant Human Hyaluronidase), Expanding its Use to a Broader Group of Patients with Secondary Immunodeficiencies.