Takeda’s HYQVIA® Receives EU Label Expansion for Use in Adults, Adolescents, and Children with Secondary Immunodeficiency (SID)

September 16, 2020 News /BioValleyBIOON/ -- Takeda recently announced that the European Commission (EC) has approved a label update for HyQvia (human normal immunoglobulin (10%), recombinant human hyaluronidase), expanding its indications to make it the first and only convenient subcutaneous immunoglobulin replacement therapy for a broader population of patients with secondary immunodeficiency (SID), including adults, adolescents, and children.

With the latest label update, HyQvia is now indicated as an alternative therapy for adult, pediatric, and adolescent (0–18 years) patients with primary immunodeficiency (PID), specifically those experiencing severe or recurrent infections, inadequate response to antimicrobial therapy, documented failure of specific antibody production (PSAF), or serum IgG levels <4 g/L.

Previously, HyQvia was approved: as a replacement therapy for adults, children, and adolescents (0–18 years) with primary immunodeficiency syndromes characterized by impaired antibody production.

This label update is based onClinical Trialsubstantial evidence indicating that subcutaneous immunoglobulin reduces the infection rate in patients with SID. Previously, the European Medicines Agency (EMA) had updated the Summary of Product Characteristics (SmPC) for intravenous human normal immunoglobulin (IVIg), which became effective in 2019. The efficacy and safety of HyQvia were also evaluated in a retrospective single-center study involving patients with hematologic malignancies.TumorPatients with secondary immunodeficiency were evaluated. The safety profile of HyQvia remained unchanged following the label expansion.

HyQvia is a two-vial package consisting of one vial of human normal immunoglobulin (IGI, 10%) and one vial of recombinant human hyaluronidase (rHuPH20), intended for subcutaneous (SC) administration. Hyaluronidase facilitates the dispersion and absorption of immunoglobulin (IGI) in the subcutaneous tissue. HyQvia allows for subcutaneous administration every 3 or 4 weeks, serving as an alternative to intravenous infusion or more frequent SC administration.

Primary Immunodeficiency (PID) is caused by more than 400 types ofHereditya group of diseases characterized by absent or impaired immune system function in some individuals. Globally, an estimated 6 million people may have PID, but only 650,000 have beenDiagnosisOut.

Secondary Immunodeficiency (SID) occurs in patients whose immune systems are weakened due to disease or therapeutic interventions. Both conditions can lead to impaired or insufficient antibody production, resulting in a risk of recurrent severe infections and hospitalization. It is estimated that SID is 30 times more common than Primary Immunodeficiency (PID). The increased use of B-cell-targeted therapies may also contribute to the prevalence of SID. SID is typically initially managed with prophylacticAntibioticsTreatment. In preventiveAntibioticsIn patients with immunodeficiency or impaired immune function, alternative immunoglobulin (IG) has been proven to effectively reduce infections. (Bioon.com)

Original Source: European Medicines Agencyapproves Label Update for HYQVIA® (Human Normal Immunoglobulin 10% and Recombinant Human Hyaluronidase), Expanding its Use to a Broader Group of Patients with Secondary Immunodeficiencies