EMA approves label update for Takeda’s HYQVIA, expands use to treat secondary immunodeficiencies
It was based on evidence from clinical trials that demonstrated that subcutaneous administration of immunoglobulin has been shown to decrease the rate of infections in patients with SID
Takeda Pharmaceutical announced that the European Medicines Agency (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 (SID). With the update, HYQVIA is now indicated for use as replacement therapy in adults, children and adolescents (0-18 years) with SID who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven scientific antibody failure (PSAF) or serum IgG level of <4 g/l.
The label update was based on the body of evidence from clinical trials that have demonstrated that subcutaneous administration of immunoglobulin has been shown to decrease the rate of infections in patients with SID and follows an update made by the EMA to the Summary of Product Characteristics (SmPC) for human normal immunoglobulin for intravenous administration (IVIg) which went into effect in 2019. The efficacy and safety of HYQVIA have also been evaluated in a retrospective single-centre study in patients with immunodeficiencies secondary to hematologic malignancies. The safety profile of HYQVIA has remained unchanged with the expanded label.
“With this expanded label, an expanded range of patients suffering from secondary immunodeficiencies now have HYQVIA as an option offering the flexibility of once-a-month treatment self-administered at home or with support of a medical professional in a healthcare setting,” said Kristina Allikmets, Head of Plasma Derived Therapy Research & Development at Takeda.