Takeda HyQiva has been approved by the European Union to update the label

Takeda recently announced that the European Commission (EC) has approved a label update for HyQvia (10%), recombinant human hyalurase, expanding its use to make it the first and only easy-to-use subsurface immunoglobulin replacement therapy for a wider group of secondary immunodeficiency (SID) patients, 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 <4g/L.HyQvia has previously been 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-cortical injection of immunoglobulin can reduce infection rates in SID patients. Previously, the EMA has updated the product characteristics summary (SMPC) of intravenous human normal immunoglobulin (IVIg) and is in effect in 2019. HyQvia's efficacy and safety were also evaluated in patients with secondary immunodeficiency of blood malignancies in a retrospective single-center study. HyQvia's security 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 allows subsection medication 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. Globally, an estimated 6 million people 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. It is estimated that SID is 30 times more common than PID. Increased use of treatments for B cells may also lead to the popularity of SID. SID is usually initially treated with preventive antibiotics. Alternative immunoglobulin (IG) has been shown to be effective in reducing infection in patients who have failed or been banned by prophylactin antibiotics.
(Bio Valley
)original source: European Pharmaceuticals Aapproves Label Update for HYQVIA® (Human Normal Immunoglobulin 10% and Recombinant Human Hyaluronidase), Expanding Its Use to a Broader Group of Patients with Secondary Immunodeficiencies